Evaluation of efficacy and safety of a single dose Tranexamic acid in reducing blood loss during colorectal cancer surgery. A randomised, placebo controlled, double-blinded study.

Background and Aims: Colorectal cancer surgeries are commonly performed nowadays. They are considered as extensive procedures requiring perioperative blood transfusion in 32% to 68% of cases. The objective of this study was to evaluate the anti-haemorrhagic effects and safety of a single dose of tranexamic acid in such surgeries. Methods: Sixty patients scheduled for colorectal cancer surgeries were randomly assigned (TA) into two equal groups. Group TA received 10 mg/kg tranexamic acid in 100 ml of 0.9% NaCl immediately following induction of anaesthesia and control group received 100 ml 0.9% NaCl. The primary outcome was total blood loss reduction. The secondary outcomes were total number of patients requiring blood transfusion and occurrence of any thromboembolic events within 30 days after surgery. Results: Intraoperative and total blood loss were lower in TA group compared to the control group (P = 0.010, 0.003, respectively) while postoperative blood loss was comparable between both groups. The need for blood transfusion was lower in TA group (P = 0.038). Number of blood units transfused was also lower in TA group. Mean arterial blood pressure, serum creatinine and urine output in first 24 h postoperatively were comparable between both groups. Haemoglobin level in the first postoperative day was higher in TA group (P = 0.002), but was comparable between the groups at 2 weeks preoperative and from second up to fifth day postoperatively. Conclusion: A single dose of TA administered between induction and start of surgical procedure may reduce total blood loss and need of transfusion in colorectal cancer surgeries without any serious adverse effects.

Comparative Study Between Early versus Late Intraperitoneal Administration of Either Bupivacaine/Tramadol or Bupivacaine/Dexmedetomidine for Perioperative Analgesia in Abdominal Laparoscopic Cancer Surgeries: A Prospective Randomized Study.

Objective: Several modalities for analgesia after laparoscopic procedures have been used. This study aimed to investigate the efficacy of early versus late bupivacaine/tramadol combination and bupivacaine/dexmedetomidine combination in analgesia for laparoscopic cancer surgeries. Methods: A total of 100 patients of both genders scheduled for elective laparoscopic cancer surgeries were included. Patients were randomly assigned to one of four groups each comprises 25 patients. Group 1: early bupivacaine/tramadol, Group 2: late bupivacaine/tramadol, Group 3: early bupivacaine/dexmedetomidine, and Group 4: late bupivacaine/dexmedetomidine. Early groups received the intraperitoneal instillation before start of surgery and late groups received the instillation after completion of surgery. Perioperative heart rate (HR) and mean arterial blood pressure (MAP) were recorded. The degree of postoperative pain was measured at rest and with cough using Visual analogue scale (VAS) score at 2, 4, 6, 12, 18 and 24 h after surgery. In addition, the total intraoperative fentanyl and postoperative morphine doses were calculated. Results: Both late bupivacaine/tramadol, bupivacaine/dexmedetomidine groups had longer time to receive first analgesic requirement (13.4±3.9, 11.3±3.9 h) respectively as compared to early bupivacaine/tramadol, bupivacaine/dexmedetomidine groups (9.8± 3.6, 8.4± 2.8 h), respectively. Between each early and late group, intraoperative fentanyl consumption was higher for the late groups (75± 22.8, 73± 21.55µg) versus (32.7± 10.9, 37.5± 13.3 µg), respectively. As regards to rescue analgesic requirements, both early bupivacaine/tramadol and bupivacaine/dexmedetomidine groups consumed more analgesics (5.2± 2.0 and 6.1± 1.8 mg) as compared to the late groups (3.2± 0.8 and 4.3± 1.5 mg), respectively. The four groups were comparable for their perioperative HR and MAP values. Conclusion: Intraperitoneal instillation of bupivacaine/tramadol and bupivacaine/dexmedetomidine could be considered an effective route for analgesic administration during laparoscopic cancer surgeries. Early instillation reduced the intraoperative opioid consumption and late instillation resulted in reduced postoperative opioid consumption. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04813016.

The role of duloxetine in reducing opioid consumption after thoracotomy: a prospective, randomized, double-blinded, placebo-controlled pilot trial.

BACKGROUND: Exploration of the thoracic cavity through a thoracotomy incision for thoracic malignancies is accompanied by severe, excruciating acute postoperative pain. The objective of this study is to evaluate the efficacy of perioperative duloxetine when given as part of a multimodal analgesia in reducing the dose of opioids needed to treat acute postoperative pain after thoracotomy. METHODS: Sixty patients scheduled for thoracotomy were randomly assigned to one of two treatment groups. The duloxetine group (D) received duloxetine 60 mg orally two hours before the surgical procedure and 24 hours after surgery, and the placebo group (P) received oral equivalent placebo capsules during the same time schedule. The primary outcome was the postoperative consumption of narcotics. Secondary outcome measures were assessment of postoperative pain scores (VAS) during rest, walking and coughing, hemodynamic variables and development of any side effects. RESULTS: Total dose of morphine needed to treat postoperative pain in first 48 hours, intraoperative isoflurane concentrations, intra- and postoperative epidural infusion rates all were significantly lower in group D (P<0.001). Postoperative pain at rest (VAS-R) was significantly less frequent in group D compared to group P at all-time intervals so as during walking (VAS-W) (P<0.001). While during cough (VAS-C), it was comparable at all time point except at 12 hours which was significantly low in group D (P<0.001). The intra-, postoperative mean blood pressure and development of side effects were comparable between the two groups. CONCLUSIONS: Oral duloxetine used perioperatively during thoracic surgery may play an important role as multimodal analgesia for acute postoperative pain without any added side effects.

The Role of Double Modality Ultrasonographic and Fluoroscopic Guided Superior Hypogastric Plexus Neurolysis in Treating Intractable Pelvic Cancer Pain: A Comparative Study.

BACKGROUND: Superior hypogastric neurolytic block is performed to block visceral pelvic pain. This could be performed through the anterior approach guided by CT or ultrasound and through a posterior approach, guided by fluoroscopy or CT. METHODS: Sixty adult patients with severe visceral pelvic pain (VAS>70 mm) were randomly divided into two groups. Group S: SHP block was done ultrasound guided using the anterior approach and confirmed by fluoroscopy. Group F: SHP block was done fluoroscopic guided using the posterior oblique approach. The VAS (visual analog scale), duration of the technique, time of X-ray exposure, patient satisfaction score, patient global impression of change (PGIC), quality of life score, and daily morphine consumption (mg/day) were measured pre-procedure and at the 1st, 4th, 8th, and 12th week after the procedure. In addition, any side effects of the procedure were recorded. RESULTS: There was a significant difference in VAS between the two groups (P<0.01) (better in group S). The quality of life score was improved from the pre-procedure in both groups (P<0.05), and morphine consumption was significantly lower in group S than in group F (P<0.05) at the 1st, 4th, and 8th week and not significant at the 12th week. The two groups show a statistically significant difference as regards the duration of the procedure and X-ray exposure (P<0.01). There was a statistically significant difference in the satisfactory score between the two groups at the 1st, 4th, 8th, and 12th week (P<0.01). As regards the PGIC score, there was no statistically significant difference between the two groups (P>0.05). In group S, no back pain was reported, while 11 patients of group F complained from post-procedure back pain (P<0.001). CONCLUSION: The anterior ultrasound guided SHPB aided by fluoroscopy is suggested to be more superior to the standard fluoroscopic guided technique in relieving pelvic cancer pain and decreasing morphine consumption.

The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study.

OBJECTIVE: The aim of this randomized controlled trial was to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumours. METHODS: This trial included 89 patients with chest malignancies, scheduled for thoracotomy were randomly allocated into two groups: Group A "PCA-group N=44" receiving patient-controlled analgesia and group B "SAPB group N=45" where analgesia was provided by SAPB. The primary outcome measure was the assessment for the possible emergence of PTPS at 12 weeks. The secondary outcome measures were pain relief measured using visual analog scale (VAS) score, Quality of life was assessed using Flanagan Quality of Life Scale (QOLS) and Activity level was assessed using Barthel Activity of daily living (ADL) score. RESULTS: At week 8, PTPS incidence was significantly (p = .037) higher in the PCA group (45%) than in the SAPB group (24%) with a relative risk of 1.38 and 95% CI (1.01-1.9) while the incidence of PTPS at week 12 was significantly (p = .035) higher in the PCA group (43%) than in the SAPB group (22%) with a relative risk of 2.38 and 95% CI (1.23-4.57). The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than the PCA group (38.6%) (p = .028) at week 12. Pain intensity: VAS-R and VAS-D (pain scores at rest and with activity, respectively) was comparable (p > .05) between both groups at 6, 12, 18 and 24 hr, however VAS was significantly higher in the PCA group at week 8 (p = .046) and week 12 (p = .032) . Both groups were comparable regarding ADL and QOL scores (p > .05). CONCLUSION: Serratus anterior plane block is assumed to be a good alternative for post-thoracotomy analgesia following thoracotomies. The current work hypothesized that SAPB for a week postoperatively, may reduce the emergence of PTPS and may reduce the demand for pain therapy in those patients. SIGNIFICANCE STATEMENT: The current work hypothesized that SAPB for a week postoperatively, is a good loco-regional alternative for post-thoracotomy analgesia following thoracotomies for chest malignancies, it may reduce the emergence of PTPS and the demand for pain therapy in these patients.

Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance: a randomized clinical trial.

BACKGROUND: This study is comparing thermal radiofrequency ablation (TRFA) of the thoracic dorsal root ganglia (TDRG) guided by Xper CT and fluoroscopy with the standard fluoroscopy. METHODS: This randomized clinical trial included 78 patients suffering from chronic refractory pain due to chest malignancies randomly allocated into one of two groups according to guidance of TRFA of TDRG. In CT guided group (n = 40) TRFA was done under integrated Xper CT-scan and fluoroscopy guidance, while it was done under fluoroscopy guidance only in standard group (n = 38). The primary outcome was pain intensity measured by visual analog scale (VAS) score, functional improvement and consumption of analgesics. The secondary outcome measures were patient global impression of changes (PGIC) and adverse effects. RESULTS: VAS scores decreased in the two groups compared to baseline values (p < 0.001) and were lower in CT guided group up to 12 weeks. Pregabalin and oxycodone consumption was higher in the standard group at 1, 4 and 12 weeks (p < 0.001). Functional improvement showed near significant difference between the two groups (P = 0.06 at week 1, 0.07 at week 4 respectively) while the difference was statistically significant at week 12 (P = 0.04). PGIC showed near significant difference only at week 1 (P = 0.07) while the per-patient adverse events were lower in CT guided group (p = 0.027). CONCLUSIONS: Integrated modality guidance with Xper CT-scan and fluoroscopy together with suprapedicular inferior transforaminal approach may improve efficacy and safety of TRFA of TDRG for the treatment of intractable chest pain in cancer patients. TRIAL REGISTRATION: The study was retrospectively registered at clinicaltrials.gov on 04/22/2018 (Registration No.: NCT03533413).

Levosimendan for patients with heart failure undergoing major oncological surgery: A randomised blinded pilot study.

BACKGROUND AND AIMS: Cardiovascular diseases and cancer are among the leading causes of mortality worldwide. The aim of this study is to evaluate the efficacy and safety of preoperative administration of levosimendan in patients with chronic heart failure (CHF) scheduled for major abdominal oncologic surgery. METHODS: This study included 60 patients with abdominal malignancy, ejection fraction (EF) <35% and CHF scheduled for surgery under isoflurane-fentanyl anaesthesia and were managed in the surgical intensive care unit perioperatively. They were randomised to receive levosimendan infusion (n = 30) at a dose of 0.1 µg/kg/min or placebo (n = 30) for 24 hours before surgery. RESULTS: The risk of hypotension (RR: 0.40, 95% CI: 0.19-0.83) or decompensated heart failure (RR: 0.31, 95% CI: 0.12-0.76) was significantly lower in the levosimendan group. The ejection fraction, cardiac index and stroke volume index were significantly higher in the levosimendan group after surgery (P < 0.001). Duration of postoperative ventilation and hospital stay were significantly shorter in the levosimendan group (P < 0.001) while the frequency of dysrhythmia, deterioration of renal function and sepsis was comparable. CONCLUSION: In patients with low EF <35% and CHF, administration of levosimendan for 24 hours before major abdominal oncologic surgeries may reduce the risk of hypotension and decompensated heart failure and may improve cardiac function.

The Possible Preventive Role of Pregabalin in Postmastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial.

CONTEXT: Chronic postmastectomy pain syndrome (PMPS) has a considerable negative impact on the quality of life of breast cancer patients. OBJECTIVE: The objective of this study was to assess the possible preventive role of perioperative pregabalin in PMPS. METHODS: This randomized controlled study included 200 patients with breast cancer scheduled for elective breast cancer surgery. They were randomly assigned to one of two treatment groups. The pregabalin group received 75 mg of pregabalin twice daily for seven days and the control group received oral equivalent placebo capsules. The primary outcome was development of neuropathic PMPS. Neuropathic pain was assessed using the Grading System for Neuropathic Pain. Secondary outcome measures were safety and Visual Analogue Scale scores. RESULTS: Neuropathic pain was significantly less frequent in the pregabalin group compared to the control group at four weeks (P = 0.005), 12 weeks (P = 0.002), and 24 weeks (P < 0.001) postoperatively. PMPS was diagnosed in 11 patients (11%) of the pregabalin group and 29 patients (29%) of the control group (P < 0.001, relative risk: 0.26, 95% CI: 0.12-0.56). At the three follow-up time points, Visual Analogue Scale scores during the first three postoperative weeks were comparable in both groups while they were significantly lower in the pregabalin group at 4, 12, and 24 weeks. These two groups were comparable in the frequency of adverse events (P = 0.552). CONCLUSION: Perioperative oral pregabalin 75 mg twice daily, starting at the morning of surgery and continued for one week, could reduce the frequency of postmastectomy pain syndrome.