CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Ropivacaine +7 moredrug
Likely dose
Ropivacaine 30 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03570541
NCT03570541Phase 4Completed

Improving Perioperative Pain Management for Laparoscopic Surgery Due to Colon Cancer Using the Ultrasound-guided Transmuscular Quadratus Lumborum Block. A Double Blind, Randomized, Placebo Controlled Trial.

Zealand University Hospital·interventional·Posted Jun 27, 2018·Updated Jan 15, 2021

In Brief

A Phase 4 clinical trial evaluating Ropivacaine, Acetaminophen, and 6 other interventions for Postoperative Pain. Completed, enrolled 69 participants across 1 site.

Detailed Summary

Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia. An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore. Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen. The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartJun 28, 2018
Primary CompletionDec 5, 2020
Study CompletionJan 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.0 years ago

Interventions

Ropivacainedrug

30 mL ropivacaine 0,375% administered on each side as bilateral TQL blocks

Acetaminophendrug

Every six hours postoperative, all patients are administered 1 g of acetaminophen.

Patient controlled analgesiadevice

PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.

Morphinedrug

intravenously administered morphine via PCA-pump

Salinedrug

30 ml saline 0,375% administered on each side as bilateral TQL blocks

Blood samplesother

On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis

Quality of recovery-15 questionairebehavioral

On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire.

Orthostatic hypotensionother

Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.