Autologous re-transfusion drain compared with no drain in total knee arthroplasty: a randomised controlled trial.

BACKGROUND: Post-operative anaemia following total knee arthroplasty is reported to impede functional mobility in the early period following surgery, whereas allogeneic blood transfusions, used to correct low post-operative haemoglobin levels, have concomitant disadvantages. The use of a post-operative autologous blood re-transfusion drainage system as well as no drainage system following total knee arthroplasty have been shown to reduce peri-operative blood loss and allogeneic blood transfusions, compared to the regularly used closed-suction drains. No randomised studies have been performed, to the best of our knowledge, that indicate the superiority of either method. MATERIALS AND METHODS: An open, randomised controlled study was conducted in 115 patients undergoing total knee arthroplasty who were randomly allocated to an autotransfusion drain or no drainage system. The primary end-point was haemoglobin level on the first post-operative day. RESULTS: In the autotransfusion group 515 mL (0-1,500 mL) of drained blood was re-transfused within the first 6 hours after surgery. Haemoglobin levels on the first (11.6 vs 11.0 g/dL), second (11.0 vs 10.3 g/dL) and third (10.5 vs 9.8 g/dL) days after surgery were significantly higher in the autotransfusion group. Total peri-operative net blood loss (1,576 mL vs 1,837 mL; -P=0.03) and allogeneic transfusion rates (10.2% vs 19.6%; P=0.15) were lower in the autotransfusion group. There were no differences in pain scores, range of motion or adverse events during hospital stay and the first 3 months after surgery. DISCUSSION: Compared with no drainage, the use of a post-operative autologous blood re-transfusion drainage system following total knee arthroplasty results in higher post-operative haemoglobin levels and less total blood loss.

Autologous platelet gel in total knee arthroplasty: a prospective randomized study.

PURPOSE: Total knee arthroplasty (TKA) is often associated with major postoperative blood loss, postoperative pain, and impaired wound healing. The application of autologous platelet gel (APG), prepared from the buffy coat of a unit of autologous blood, has been advocated to improve haemostasis after surgery, to decrease perioperative blood loss, diminish postoperative pain and to enhance the wound healing process. This randomized controlled pilot study was developed to assess the effects of APG after total knee arthroplasty on blood loss, wound healing, pain, range of motion, and hospital stay. METHOD: A prospective, randomized observer blind controlled trial was performed. Forty patients with only osteoarthritis of the knee were scheduled to have a TKA, and they were randomized into two groups. Patients in the treatment group were all treated with the application of autologous platelet gel after the prosthesis was implanted. Patients in the control group were treated with the same protocol but no APG was used. RESULTS: Preoperative and postoperative Hb levels showed no significant difference and allogenic blood transfusions were not given in either group. Haematomas were significantly larger in the control group than in the platelet gel group (P = 0.03). The pain score at rest was higher in the control group on the 3rd day (P = 0.04). Wound healing disturbances were seen in four patients in the control group and in no patients in the APG group (n.s.). Range of motion of the knee was similar postoperatively. Hospital stay was 6.2 days in the APG and 7.5 days in the control group (n.s.). CONCLUSION: In this prospective randomized pilot study on APG in total knee arthroplasty, differences in favour of the use of platelet gel were found, but these were subjective evaluations, marginal in effect, or did not reach statistical significance. The use of drains might have decreased the concentration of delivered platelets and may have diminished the effect. However, in this study, a statistically significant clinically important effect in favour of platelet gel application was not found. Further studies with larger numbers of patients, and without the use of drains, are warranted to investigate the possible benefits of autologous platelet gel in total knee arthroplasty.

Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine.

BACKGROUND: Some patients with long-standing low back pain will benefit from treatment with strong opioids. However, it would be helpful to predict which patients will have a good response. A fixed-term opioid trial has been recommended, but there is little evidence to suggest how long this trial should be. We assessed data from a large-scale randomized comparison of transdermal fentanyl (TDF) and sustained-release oral morphine (slow-release morphine; SRM) to determine characteristics of treatment responders. METHODS: This was a secondary analysis of a previously published 13-month randomized trial involving 680 patients with long-standing low back pain (median age 52 years, 61% women, median duration of back pain 87 months). Pain relief was recorded using visual analogue scales (VAS). Treatment response was defined as pain relief of at least 30% from baseline to any point during the trial. We used a step-wise logistic regression to identify variables that might predict response to treatment. Covariates included treatment group, sex, age, duration of pain, presence of neuropathic pain, baseline pain scores, educational/employment status, use of high doses of opioids, and social functioning (SF)-36 scores. RESULTS: Over half the patients in both groups (n = 370; 54% TDF, 55% SRM) were treatment responders. There were no differences between the TDF and SRM responders in terms of age, sex, type or duration of pain between responders and non-responders. The difference in response to treatment between responders and non-responders could be detected at 3 weeks. Lack of response after 1 month had a stronger negative predictive value (i.e., ability to detect non-responders) than the presence of response after 1 month. The most influential factors for predicting a response were employment status (chi2 = 11.06, p = 0.0259) and use of high doses of opioids (chi2 = 3.04, p = 0.0811). CONCLUSION: No clear pattern of baseline pain (type or severity) or patient characteristics emerged that could be used to predict responders before the start of opioid treatment. However, a 1-month trial period appears sufficient to determine response and tolerability in most cases.

Patients with and without rheumatoid arthritis benefit equally from preoperative epoetin-alpha treatment.

BACKGROUND: Preoperative epoetin-alpha administration is said to have a limited effect in patients with chronic inflammatory diseases such as rheumatoid arthritis (RA), due to lower iron availability. We studied the effects of preoperative epoetin-alpha treatment in orthopedic surgery patients in a daily life setting in which iron supplementation was assured, and compared the effects in RA and non-RA patients. METHODS: In an open, naturalistic, randomized controlled trial, 695 orthopedic surgery patients with preoperative hemoglobin (Hb) values of 10-13 g/dL, either with RA (113) or without RA (582), received either preoperative epoetin-alpha treatment added to standard care, or standard care alone. Hb values and transfusions were evaluated from entry into the study until 4-6 weeks after surgery. RESULTS: Both in RA and non-RA patients, perioperative Hb values were significantly higher and transfusion requirements were significantly lower in epoetin-alpha treated patients than in control patients (p < 0.001). In RA patients, the outcomes regarding Hb values were not significantly or relevantly different from non-RA patients. INTERPRETATION: Just as with orthopedic patients in general, RA patients benefit from preoperative epoetin-alpha treatment in combination with iron supplementation. We postulate that iron supplementation during epoetin-alpha therapy in RA patients is important for optimal efficacy.

Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain.

BACKGROUND: The Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire is a 12-item self-report instrument divided into abdominal, rectal and stool domains. AIMS: This study aimed to (1) evaluate the psychometric properties of PAC-SYM in assessing the symptoms and severity of opioid-induced constipation; (2) test for differences in opioid-induced constipation between Durogesic fentanyl transdermal reservoir (TDF) and oral sustained-release morphine (SRM) in patients with chronic low back pain (CLBP). METHODS: In a 13-month, open-label, parallel-group study, 680 patients were randomised to receive either TDF (n=338) or SRM (n=342) for CLBP. Assessments were recorded at Visit 1 (baseline), Visit 5 (Day 29) and Visit 17 (Month 13). Concurrent validity, clinical validity and responsiveness of PAC-SYM were determined based on patients' confirmation of constipation (CC) scores. Differences in PAC-SYM scores between treatment groups were also evaluated. RESULTS: The study included 677 patients, of whom 638 were opioid-naïve. Mean PAC-SYM scores for constipated patients were substantially higher than for non-constipated patients, demonstrating good clinical validity for PAC-SYM. The PAC-SYM could detect changes in bowel function over the treatment period, indicating responsiveness. Homogeneity of each symptom domain exceeded Cronbach's alpha coefficient of 0.70, suggesting good internal consistency and reliability. Changes in mean PAC-SYM scores from baseline to Visit 5 and Visit 17 were significantly lower for the TDF group than for the SRM group, indicating that the TDF group experienced less severe constipation. CONCLUSION: PAC-SYM is a reliable, valid and responsive measure of the presence and severity of opioid-induced constipation symptoms.

Transdermal fentanyl versus sustained release oral morphine in strong-opioid naïve patients with chronic low back pain.

STUDY DESIGN: Open, randomized, parallel group multicenter study. OBJECTIVES: To compare the efficacy and safety of transdermal fentanyl (TDF) and sustained release morphine (SRM) in strong-opioid naïve patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Most studies of TDF and SRM have involved patients already receiving strong opioids. This is the first large-scale study focusing on strong-opioid naïve patients with CLBP. METHODS: Adults with CLBP requiring regular strong opioid therapy received either TDF or SRM for 13 months. Starting doses were 25 microg/hr fentanyl patches every 72 hours or 30 mg oral morphine every 12 hours. Doses were adjusted according to response. Participants assessed pain relief and bowel function using weekly diaries. Other assessments, including quality of life, disease progression, and side effects, were made by patients and investigators. RESULTS: Data from 680 patients showed that TDF and SRM provided similar levels of pain relief, but TDF was associated with significantly less constipation than SRM, indicating a greater likelihood of satisfactory pain relief without unmanageable constipation for patients receiving TDF. Other ratings were similar for TDF and SRM, but TDF provided greater relief of pain at rest and at night. CONCLUSIONS: TDF and SRM provided equivalent levels of pain relief, but TDF was associated with less constipation. This study indicates that sustained-release strong opioids can safely be used in strong-opioid naïve patients.

Successful defibrillation immediately after the intravascular injection of ropivacaine.

PURPOSE: To report successful resuscitation of ventricular fibrillation induced by accidental intravascular injection of ropivacaine. CLINICAL FEATURES: A 15-yr-old healthy girl weighing 59 kg was scheduled for transposition of the tibial tuberosity under combined sciatic/three-in-one block. No premedication was given. In the induction room, an iv infusion was started, along with electrocardiogram monitoring, non-invasive blood-pressure measurement and pulse-oximetry. The sciatic nerve was found with the use of a nerve stimulator at the first attempt by the classical approach of Labat. Aspiration for blood was negative and the injection of ropivacaine 0.75% without epinephrine started. Convulsions, followed within seconds by ventricular fibrillation occurred at the end of the injection of 18 mL ropivacaine 0.75%. Oxygen was administered by face mask ventilation and immediate defibrillation was successful on the second attempt (2 x 200 joules). Within two minutes convulsions stopped and normal cardiac rhythm returned. Propofol and sufentanil were injected and a laryngeal mask inserted to start general anesthesia for surgery. Postoperatively no evidence of sciatic block could be demonstrated. The patient did not remember the event and was discharged the following day with no residual effects. CONCLUSION: This case report shows that ventricular fibrillation after unintentional intravascular injection of ropivacaine can be treated successfully when one is prepared and cardiac life support measures are taken immediately.

Perioperative blood transfusions and delayed wound healing after hip replacement surgery: effects on duration of hospitalization.

Patients who receive allogeneic blood transfusions after orthopedic surgery have a longer duration of hospitalization, and this cannot be explained by a more frequent incidence of infections in transfused patients. To determine whether transfusion of allogeneic blood interferes with wound healing and therefore increases the duration of hospitalization, we performed an observational study in 444 consecutive patients scheduled for elective primary hip surgery. Transfusion, wound, and infection variables were collected at five time points during treatment. Of the 444 consecutive patients studied, 92 received blood transfusions during their perioperative course. Thirty-one percent of transfused patients developed wound-healing disturbances versus 18% of the nontransfused group (P < 0.05); allogeneic blood transfusion was the only significant predictor for development of minor wound-healing disturbances. Duration of hospitalization was prolonged in transfused patients (12.3 versus 9.8 days) and could be predicted by 4 significant variables: requirement for blood transfusion (adds 2.7 +/- 0.5 days), presence of wound-healing disturbances (adds 1.3 +/- 0.5 days), duration of surgery (adds 0.2 +/- 0.1 days/10 min), and patient's age (adds 0.9 +/- 0.2 days/10 yr). These data suggest that allogeneic blood transfusion is associated with an increased incidence of wound-healing disturbances and that prevention of allogeneic blood transfusion may be relevant in limiting the duration of admission after elective orthopedic surgery.

An algorithm to reduce allogenic red blood cell transfusions for major orthopedic surgery.

In a previous prospective study, we confirmed that transfusion-related immunosuppression predisposes to postoperative infections, impairs the postoperative healing of wound and thereby prolongs hospitalization. This increases the well-known risks, such as transmission of infection or transfusion reactions, and has obliged us to revise our transfusion guidelines. We used a relational database containing information about 28,861 orthopedic surgery patients was used to determine when and how to improve these guidelines for transfusions. The survey showed the circumstances surrounding a high incidence of allogenic red cell infusions: failure to follow the guidelines, the preoperative use of nonselective NSAIDs, low preoperative Hb level, failure to retrieve blood, and high cut-off values for allogenic red cell transfusion. The first step was to determine the Hb level before giving red cell infusions and ensure compliance with predefined cut-off values. Subsequent measures included: use of COX 2-selective NSAIDs alone in the perioperative period; erythropoietin and iron therapy when the Hb level fell below 13 g/dL; use of cell salvage during and after surgery; administration of aprotinin to patients expected to have a high blood loss. The type of anesthesia had no blood-sparing effect. Although these steps can not be regarded as a new approach, we show that by following a strict rules with appropriate steps and in a concerted fashion, the use of allogenic red blood cells was reduced by 80%. Moreover, the amount of blood saved had other effects--e.g., the incidence of deep wound infections was reduced by 40%. The outcome is described in an algorithm summarizing the steps in a comprehensive perioperative diagram for giving blood.

Transcranial electrical motor-evoked potential monitoring during surgery for spinal deformity: a study of 145 patients.

STUDY DESIGN: A descriptive historic cohort study was conducted. OBJECTIVES: To determine intraoperative response amplitude criteria for transcranial electrical motor-evoked potential monitoring that warn of neurologic damage, and to determine the additional value of monitoring six instead of two muscle sites. SUMMARY OF BACKGROUND DATA: Transcranial electrical motor-evoked potential monitoring provides immediate and reliable information about the integrity of the motor pathways during spine surgery. Although this monitoring technique is more frequently used, criteria for interpretation of the amplitude responses have not been defined. METHODS: The intraoperative monitoring outcomes were compared with the patient's clinical outcomes. The sensitivity, specificity, positive predictive value, and negative predictive value were determined for four different monitoring criteria. RESULTS: Transcranial electrical motor-evoked potential monitoring was possible 142 of 145 patients undergoing corrective surgery. In this study, 16 patients had a neurologic event, and 11 patients showed recovery of response amplitude after a second surgical maneuver, whereas the remaining 5 patients had permanent partial neurologic damage. The criterion that at least one of six recordings must show an amplitude decrease of more than 80% was sufficiently strict to achieve a sensitivity of 1.0 and a specificity of 0.91. Less strict criteria, including recording at two instead of six sites, resulted in lower sensitivity, with the lower bound of the 95% confidence interval at 0.62. CONCLUSIONS: Transcranial electrical motor-evoked potential monitoring allowed successful intraoperative monitoring. The criterion of one recording showing a response amplitude decrease of more than 80% during a surgical action can be considered a valuable warning criterion for neurologic damage. The authors also consider that monitoring at six instead of two muscles improves the value of neuromonitoring.

Prior ibuprofen exposure does not augment opioid drug potency or modify opioid requirements for pain inhibition in total hip surgery.

PURPOSE: In previous animal studies, a prior exposure to non-steroidal anti-inflammatory drugs (NSAID) augmented opioid drug potency. This study was designed to answer the question whether a similar effect can be attained in man. The objective was to use NSAID for preoperative pain reduction and at the same time use the NSAID exposure to reduce opioid requirements for pain inhibition in major orthopedic surgery. METHODS: In this double-blind, randomized study, 50 patients scheduled for total hip surgery were included. Patients of Group I received a placebo drug three times a day two weeks before surgery, and those allocated to Group II received ibuprofen (600 mg) three times a day. For surgical anesthesia, all patients received intrathecal bupivacaine 20 mg plus 0.1 mg morphine in a total volume of 4 mL. RESULTS: The preoperative or postoperative visual analogue scale pain scores or the amount of iv morphine showed no differences between the two groups in the first 24 hr after surgery. The median total blood loss in the ibuprofen group was 1161 mL vs 796 mL in the placebo group (P < 0.01). CONCLUSION: Pretreatment with ibuprofen before major hip surgery does not improve the pain scores or reduce morphine requirement but significantly increases blood loss. Considering the presence of relevant adverse effects, pretreatment with a non-selective NSAID is not recommended.

The efficacy of radiofrequency lesioning of the cervical spinal dorsal root ganglion in a double blinded randomized study: no difference between 40 degrees C and 67 degrees C treatments.

The efficacy of radiofrequency lesion treatment of the cervical dorsal root ganglion (RF-DRG) in cervicobrachialgia was investigated in 61 patients by a randomized prospective double blinded study. Before lesion treatment the putative pain provoking spinal root was identified by diagnostic blocks with a local anesthetic agent. One group of patients (n = 32, group I) was treated with a radiofrequency lesion of 67 degrees C and in a control group (n = 29, group II) a temperature of 40 degrees C was applied. Three months after treatment a significant reduction in VAS scores was demonstrated in both groups. The outcome of the treatments was identical (VAS reduction: group I, 1.7; group II, 1.9; P = 0.001). In group I a VAS reduction of 3 or more occurred in 11/31 (34%) and in group II in 11/29 (38%) of patients. A VAS reduction of 2 or more occurred in group I in 15/31 (47%) and in group II in 15/29 (51%) of patients. This study suggests that treatment with 40 degrees C radiofrequency application of the dorsal root ganglion is equally effective as treatment at 67 degrees C. Further appraisal of this treatment is required.