Improving pain management after planned caesarean section by using catheters for continuous nerve block.

Phase 1

• Conditions: Treatment of postoperative pain after elective caesarean section.; MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10006832Term: C-sectionSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003625-15-DK
• Lead Sponsor: Zealand university hospital, Roskilde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-26
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Participants in the study need to fulfil the following criteria in order to be included:
- 18 years old or more
- Scheduled for elective Caesarean Section in spinal anaesthesia
- Have received thorough information, verbally and in written, and signed the Informed Consent” form on participation in the trial
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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Either of the following criteria will lead to exclusion of the parturient of the study:
- Inability to cooperate
- Inability to understand Danish
- Allergy to local anaesthetics or opioids
- Excessive daily intake of opioids, according to the discretion of the investigator
- Local infection at the site of injection or systemic infection
- Difficult visualisation of muscular and fascial structures on ultrasound, necessary to
correct blockade and catheter placement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours, and that bilateral TQL catheters will significantly reduce the Numerical Rating Scale (NRS) pain score (0-10/10) compared to the placebo group.;Secondary Objective: Not applicable;Primary end point(s): Time to first opioid.;Timepoint(s) of evaluation of this end point: 24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): (A) Pain intensity (NRS 0-10/10) in the study period at 3, 6, 9, 12 and 24 hours postoperatively. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the Patient-Controlled Analgesia (PCA) pump display prior to administration of the PCA boluses.<br>(B) Total morphine consumption. Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).<br>(C) Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).<br>(D) Patient satisfaction with application of the catheters.<br>(E) The degree of morphine-related side effects (PONV, itching, fatigue, etc.). <br>(F) Time from operation to ambulation.;Timepoint(s) of evaluation of this end point: 24 hours postoperative