Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Caesarean Section.

NCT03068260 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-03-23

No results posted yet for this study

Summary

ECS is a very common procedure. A 1-year retrospective survey revealed a vast opioid consumption among the new mothers of approximately (mean±SD) 35±25 mg of oral morphine in the first 24 postoperative hours despite a multimodal analgesic regimen. The adverse effects of morphine are well known and include postoperative nausea and vomiting (PONV), itching, fatigue, constipation, confusion, respiratory depression and delayed mobilization. These adverse effects are unsound for the new mothers as well as the breast-fed, newborn children. This study aims to evaluate the efficacy of bilateral Transmuscular Quadratus Lumborum (TQL) block in reducing postoperative morphine consumption and pain.

Conditions

  • Postoperative Pain

Interventions

DRUG

Ropivacaine

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

DRUG

Saline

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

DRUG

Acetaminophen

1 g orally administered postoperatively

DRUG

Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet

orally administered postoperatively

DEVICE

ultrasound-guided nerve block

Transmuscular quadratus lumborum block, ultrasound-guided

DRUG

Morphine

intravenously administered morphine via PCA-pump

DEVICE

Patient-controlled analgesia

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

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2017-12-01
Completion
2017-12-01

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 NCT03068260 on ClinicalTrials.gov