Assessment of the feasibility of high-concentration capsaicin patches in the pain unit of a tertiary hospital for a population of mixed refractory peripheral neuropathic pain syndromes in non-diabetic patients.

BACKGROUND: High-concentration-capsaicin-patches (Qutenza®) have been put on the market as a treatment for peripheral neuropathic pain. A minimum infrastructure and a determinate skill set for its application are required. Our aim was to assess the feasibility of treatment with high-concentration-capsaicin-patches in clinical practice in a variety of refractory peripheral neuropathic pain syndromes in non-diabetic patients. METHODS: Observational, prospective, single-center study of patients attended to in the Pain Unit of a tertiary hospital, ≥ 18 year-old non-responders to multimodal analgesia of both genders. The feasibility for the application of capsaicin patch in clinical practice was evaluated by means of the number of patients controlled per day when this one was applied and by means of the times used for patch application. RESULTS: Between October 2010 and September 2011, 20 consecutive non-diabetic patients (7 males, 13 females) with different diagnoses of refractory peripheral neuropathic pain syndromes, with a median (range) age of 60 (33-88) years-old were treated with a single patch application. The median (range) number of patients monitored per day was not modified when the capsaicin patch was applied [27 (26-29)] in comparison with it was not applied [28 (26-30)]. The median (range) total time to determine and mark the painful area was 9 (6-15) minutes and of patch application was 60 (58-65) minutes. No important adverse reactions were observed. CONCLUSION: High-concentration-capsaicin-patch treatment was feasible in our unit for the treatment of a population with refractory peripheral neuropathic pain. The routine of our unit was not affected by its use.

On-demand endoscopic CO2 insufflation with feedback pressure regulation during natural orifice transluminal endoscopic surgery (NOTES) peritoneoscopy induces minimal hemodynamic and respiratory changes.

BACKGROUND: Endoscopic insufflation has been associated with marked increase in intra-abdominal pressure (IAP) and hemodynamic and respiratory changes during transgastric surgery. OBJECTIVE: To investigate the hemodynamic and respiratory effects during intraperitoneal cavity exploration through 3 different natural orifice transluminal endoscopic surgery (NOTES) access locations compared with laparoscopy. DESIGN AND SETTING: Survival experiments using 40 female pigs randomized to transgastric, transcolonic, transvaginal, and laparoscopic peritoneoscopy. INTERVENTIONS: On-demand endoscopic insufflation of CO(2) with feedback pressure regulation was used in NOTES with a maximum pressure of 14 mm Hg. In the laparoscopy group, the IAP was maintained at 14 mm Hg. NOTES procedures were performed by an endoscopist (with the assistance of a gynecologist in the transvaginal group and a second endoscopist in the transgastric and transrectal groups) and laparoscopy by 2 surgeons. MAIN OUTCOME MEASUREMENTS: Invasive hemodynamic and respiratory data. Blood samples were drawn for gas analyses. RESULTS: All experiments except one in the transrectal group were completed. The IAP was significantly lower in all NOTES groups compared with the laparoscopy group. A significant increase in mean systemic arterial blood pressure was observed in the laparoscopy group at 15 and 30 minutes of intraperitoneal cavity exploration, but it remained unchanged during all NOTES procedures. An increase in airway pressures was observed at 15 and 30 minutes of peritoneoscopy in the animals undergoing laparoscopy, whereas those parameters remained unchanged in the NOTES groups. The laparoscopy group showed a significant impairment in pulmonary gas exchange (decrease in Pao(2), increase in Paco(2), and decrease in arterial pH) after 30 minutes of peritoneoscopy, whereas only a slight increase in Paco(2) was observed in the transrectal and transvaginal groups. LIMITATIONS: Healthy animal model. CONCLUSION: On-demand endoscopic insufflation of CO(2) with feedback pressure regulation can minimize the risk of hemodynamic and respiratory compromise caused by acute changes in IAP.

Inflammatory impact of NOTES peritoneoscopy is not different from that of laparoscopy: a randomized comparative study in a survival porcine model.

BACKGROUND: Inflammatory changes of different NOTES approaches remain unknown. The aim of this study was to compare the inflammatory effects of NOTES and laparoscopy. METHODS: Forty female pigs were assigned to transgastric, transrectal, and transvaginal NOTES and laparoscopic peritoneoscopy groups. Antiseptic technique was utilized for NOTES whereas laparoscopy was performed sterile. Intraperitoneal pressures were monitored and maintained below 15 mmH(2)O. Pneumoperitoneum was maintained with CO(2) in all groups. Pre- and postoperative blood samples of IL-6, Il-1ß, and TNFα, and peritoneal fluid collected at surgery were analyzed. Animals were followed daily for 14 days. At necropsy, peritoneal fluid was collected for cytokine analysis. RESULTS: Thirty-nine peritoneoscopies were successfully completed. The median procedure time was longer in the NOTES groups (57 min, range = 33-109) than in the laparoscopy group (33 min, range 32-36; P < 0.001); this was related to longer incision time and closure time. All 39 completed follow-up. Severe bleeding in the post-transrectal approach required early sacrifice of the remaining animal. Besides this, complications were similar among groups. At necropsy, adhesions were seen in four animals in the gastric group, five in the rectal group, two in the vaginal group, and two in the laparoscopic group (P = ns). There were no statistical differences in serum levels of TNFα among the groups. When serum TNFα values were expressed as the difference from the baseline, in the transvaginal group they were significantly lower than in the transrectal at 2 h [0.5 pg/ml (range = -14 to 59) vs. 60 pg/ml (range = -8 to 303); P = 0.041] and at 8 h [-5.5 pg/ml (range = -86 to 55] vs. 37 pg/ml (range = -30 to 62); P = 0.031]. The limitations of this study were that the analyses of IL-6 and Il-1ß were not possible because most of the samples were below detectable levels, it was an animal model, and the sample size was small. CONCLUSION: Inflammatory parameters are similar between NOTES and laparoscopic peritoneoscopy despite longer surgery time in the NOTES group. The vaginal route seems to reduce the inflammatory stress.

Infection during natural orifice transluminal endoscopic surgery peritoneoscopy: a randomized comparative study in a survival porcine model.

BACKGROUND: Infection in natural orifice transluminal endoscopic surgery (NOTES) remains controversial. OBJECTIVE: To estimate the frequency of infection during NOTES peritoneoscopy with different routes of access and to compare with laparoscopy. DESIGN: Prospective randomized controlled study (Canadian Classification type I). METHODS: Forty female pigs were randomly assigned to 3 NOTES (transgastric, transrectal, and transvaginal) and laparoscopic groups. Antiseptic technique was used for NOTES, whereas laparoscopy was performed in a sterile environment. Preoperative and postoperative intravenous antibiotics were administered. Closure of the transluminal access site was performed in all animals. Peritoneal fluid was collected for culture at the end of surgery and at necropsy at day 14. RESULTS: Thirty-nine peritoneoscopies were successfully completed. Necropsy confirmed complete healing of NOTES incisions, but 2 animals in the laparoscopy group had small abscesses in the abdominal incisions. There were no statistical differences in the presence of peritoneal adhesions. Positive culture results were seen in all groups at the end of the procedure and in all animals at necropsy, but this did not lead to clinical signs of gross infection. The most common organisms that colonized the peritoneum were gram-positive cocci and gram-negative bacilli from the normal swine gastrointestinal flora. LIMITATIONS: Animal model and small sample size. CONCLUSIONS: In these small series of animals and with the careful lavage and preparation used, NOTES appeared to be comparable to laparoscopy in terms of peritoneal contamination and clinical infection. Despite the adherence to a strict antiseptic protocol, peritoneal contamination occurs but does not lead to septic complications in the swine.