TQL-block for Laparoscopic Hemicolectomy

NCT03570541 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-01-15

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Ropivacaine

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

DRUG

Acetaminophen

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

DEVICE

Patient controlled analgesia

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

DRUG

Morphine

intravenously administered morphine via PCA-pump

DRUG

Saline

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

DIAGNOSTIC_TEST

Blood samples

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

BEHAVIORAL

Quality of recovery-15 questionaire

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

DIAGNOSTIC_TEST

Orthostatic hypotension

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

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Katrine Tanggaard, MD · Department of Anaesthesiology, Zealand University Hospital, Roskilde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2020-12-05
Completion
2021-01-03

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570541 on ClinicalTrials.gov