Continuous TQL Block for Elective Cesarean Section

Phase 4

Completed

• Conditions: Anesthesia, Local; Postoperative Pain
• Interventions: Drug: Ropivacaine; Drug: Saline

• Registration Number: NCT03663478
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-04
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-10
• Primary Completion: 2020-04-08
• Study Completion: 2020-04-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• 18+ years of age.
• 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.

Exclusion Criteria

• 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
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ropivacaine	Ropivacaine
Control	Saline	Isotonic saline

Primary Outcome Measures

Name	Time	Method
Time to first opioid	24 hours postoperatively	The time from catheters placement to the administration of opioids

Secondary Outcome Measures

Name	Time	Method
Pain intensity (NRS 0-10/10)	24 hours postoperatively	NRS (numeric rating scale) score 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. NRS is a pain scale where the patient gives her pain a number from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Total morphine consumption.	24 hours	Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).
Catheter displacement.	24 hours	Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).
Patient satisfaction with application of the catheters.	24 hours	NRS 0-10/10 during placement of catheters
The degree of morphine-related side effects (PONV, itching, fatigue, etc.).	24 hours	On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe.
Time from operation to ambulation.	24 hours	Time from operation to ambulation.

Trial Locations

Locations (1)

Department of anaesthesiology; 🇩🇰 Roskilde, Denmark