Continuous TQL Block for Elective Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-04-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour

Control

Isotonic saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour

Interventions

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Ropivacaine

2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour

Intervention Type DRUG

Saline

2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No