Clinical trial NCT05831761: Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
Official title: Effectivness of Tramadol or Topic Lidocaine on Postoperative Analgesia in Laparoscopic Colorectal Resection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative analgesia
neuropathic pain
laparoscopic colorectal surgery
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 parallel groups with different method of analgesia after laparoscopic colorectal resection.
Primary purpose: TREATMENT

Brief summary: Comparison of different postoperative analgesia after laparoscopic colorectal surgery

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* scheduled elective laparoscopic colorectal surgery

Exclusion Criteria:

* critical preoperative state, pregnant women, laparotomy and palliative procedures.

Primary outcomes:
measure: Total opioid consumption
timeFrame: 0-48 hours after surgical procedure
measure: Presence of neuropathic pain
timeFrame: first 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Ljubljana
name: Matej Jenko
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
citation: Tikuisis R, Miliauskas P, Samalavicius NE, Zurauskas A, Samalavicius R, Zabulis V. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial. Tech Coloproctol. 2014 Apr;18(4):373-80. doi: 10.1007/s10151-013-1065-0. Epub 2013 Sep 13.