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

NCT03068260 | Completed Phase 4 DMC

• 1 other identifier: ZUH-TQL-ECS
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caesarean section; postoperative pain; transmuscular quadratus lumborum block; reduction of opioid consumption

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Data from PCA pump and patient medical record

  Twenty-four hours postoperatively

Secondary Outcomes (6)

• Pain intensity (NRS 0-10/10)

  At 6, 12, 24, 36, 48 hours postoperatively.

• Total morphine consumption.

  At 6, 12, 36 and 48 postoperative hours.

• Duration of block

  Time to first opioid within the first 24 postoperative hours.

• Patient satisfaction with application of the block. Satisfaction measured on NRS.

  Immediately after application

• The degree of morphine-related side effects. Nausea or PONV registered on CRF if any.

  48 hours

Study Arms (2)

Active

ACTIVE COMPARATOR

Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot. In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

Drug: Ropivacaine; Drug: Acetaminophen; Drug: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet; Device: ultrasound-guided nerve block; Drug: Morphine; Device: Patient-controlled analgesia

Placebo

PLACEBO COMPARATOR

Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot. In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

Drug: Saline; Drug: Acetaminophen; Drug: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet; Device: ultrasound-guided nerve block; Drug: Morphine; Device: Patient-controlled analgesia

Interventions

Ropivacaine DRUG

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

Active

Saline DRUG

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

Placebo

Acetaminophen DRUG

1 g orally administered postoperatively

Active; Placebo

Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet DRUG

orally administered postoperatively

Active; Placebo

ultrasound-guided nerve block DEVICE

Transmuscular quadratus lumborum block, ultrasound-guided

Active; Placebo

Morphine DRUG

intravenously administered morphine via PCA-pump

Active; Placebo

Patient-controlled analgesia DEVICE

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

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Only women scheduled for elective caesarean section are eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women scheduled for elective Caesarean Section in spinal anaesthesia.
• Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the trial

You may not qualify if:

• Inability to cooperate
• Inability to speak and understand Danish
• Allergy to local anaesthetics or opioids
• Daily intake of opioids
• Local infection at the site of injection or systemic infection
• Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

ZUH

Roskilde, Danmark, 4000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride; Acetaminophen; Ibuprofen; Tablets; Morphine; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Dosage Forms; Pharmaceutical Preparations; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 1, 2017
• Study Start: March 15, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)