Improving pain management after caesarean section with regional anaesthesia.

Ultrasound-guided Transmuscular Quadratus Lumborum block for elective caesarean section. A double blind, randomized, placebo controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004594-41-DK

Enrollment

Registered

2016-11-22

Start date

2017-01-13

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain and opioid consumption after elective caesarean section. MedDRA version: 19.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Ropivacain Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Infiltration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Parturients scheduled for elective Caesarean Section in spinal anaesthesia. Participants most have read and understood the participants information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the efficacy of the TQL block (reduction in use of opioids in the first 24 postoperative hours) vs. Placebo in patients undergoing elective Caesarean Section.;Secondary Objective: Pain reduction, reduction of total opioid cosumption, reduction of opioid related side effects, increased patient satisfaction with block, decreased time to ambulation and duration of block i.e. increased time to first opioid;Primary end point(s): 24 hours postoperative opioid consumption;Timepoint(s) of evaluation of this end point: 24 hours after administration of block.	—

Measure

Time frame

Main Objective: To investigate the efficacy of the TQL block (reduction in use of opioids in the first 24 postoperative hours) vs. Placebo in patients undergoing elective Caesarean Section.;Secondary Objective: Pain reduction, reduction of total opioid cosumption, reduction of opioid related side effects, increased patient satisfaction with block, decreased time to ambulation and duration of block i.e. increased time to first opioid;Primary end point(s): 24 hours postoperative opioid consumption;Timepoint(s) of evaluation of this end point: 24 hours after administration of block.

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Secondary

Measure	Time frame
Secondary end point(s): Total dose of opioids during the first 48 postoperative hours, NRS (0-10) pain scores at rest a set times, time to ambulation, Postoperative Nausea and Vomiting, time to first opioid consumption (duration of block);Timepoint(s) of evaluation of this end point: 48 hours	—

Countries

Denmark

Contacts

Public ContactJens Børglum

Dept. of Anaesthesia - Copenhagen University Hospital, Roskilde

jens.borglum@gmail.com+4530700120

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026