| Registry | NCT05831761 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 83 (Actual) |
| Sponsor | University Medical Centre Ljubljana (Other) |
| Conditions | Postoperative Pain |
| Interventions | Comparison of analgesic efficacy protocol (Drug) |
| Dates | start 2009-09-01, primary completion 2011-10-01, completion 2013-10-01, first posted 2023-04-26, last updated 2023-04-26 |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Postoperative Pain All trials of Comparison of analgesic efficacy protocol
Comparison of different postoperative analgesia after laparoscopic colorectal surgery
Postoperative pain treatment should be multimodal and opioid sparing. Thoracic epidural analgesia could relieve pain after laparoscopic surgery. Although ERAS guidelines suggest to use less invasive pain relieve technique, opioids are widely used perioperatively, despite of their side effects. Non-opioids and 5% lidocaine patches, used topicaly, could effectively reduce opioid consumption and their side effects.
Namely, efficient perioperative pain treatment is important to prevent late neuropathic pain, also after laparoscopic lower abdominal surgery. Its incidence is usually low compared to open surgery.
The aim of present study was to evaluate, if opioid consumption in laparoscopic colorectal surgery could be reduced with lidocaine patch at the wound site or with infusion of metamizole and tramadol and if the results meets epidural analgesia. We also compared the incidence of postoperative neuropathic pain among groups.
Prospective, randomised trial with 4 parallel groups was conducted at the University medical centre (UMC) Ljubljana. ASA (American Society of Anaesthesiologists) Class 2-3 high risk surgical patients from the Clinical department of abdominal surgery were included in the study. Adult patients that underwent laparoscopic colorectal surgery were included.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PCA | Experimental | Drug: Comparison of analgesic efficacy protocol | Postoperative intravenous infusion of piritramid patient controlled analgesia (PCA) (piritramide 0.5 mg/ml; infusion 1,5 mg/h, bolus 1,5 mg, lock out 30 minutes) |
| PCEA | Experimental | Drug: Comparison of analgesic efficacy protocol | Postoperative patient controlled epidural analgesia (epidural cathterer inserted into Th7-8 intervertebral space, 200 ml of 0.125% levobupivacaine, 4 mg of morphine, 0.075 mg of clonidine; infusion 5 ml/h, bolus 5 ml, lock out 30 minutes). |
| tramadol | Experimental | Drug: Comparison of analgesic efficacy protocol | Continous postoperative infusion of tramadol 300 mg and metamizole 2,5 g (in 500 ml 0.9% NaCl, rate of infusion 40 ml/h) |
| lidocaine | Experimental | Drug: Comparison of analgesic efficacy protocol | Postoperative topical lidocaine and PCA (piritramide 0.5 mg/ml; infusion 0.5 mg/h, bolus 1.5 mg, lock out 20 minutes) |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: * scheduled elective laparoscopic colorectal surgery Exclusion Criteria: * critical preoperative state, pregnant women, laparotomy and palliative procedures.