Improving pain management after caesarean section with regional anaesthesia.

Phase 1

Conditions: Postoperative pain and opioid consumption after elective caesarean section.
MedDRA version: 19.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-004594-41-DK

Lead Sponsor: Jens Børglum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 72

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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