Continuous TQL Block for Elective Cesarean Section

Zealand University Hospital32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain Anesthesia, Local

Interventions

RopivacaineDRUG

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

SalineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of anaesthesiology

Roskilde, Denmark

Outcomes

Primary Outcomes

Time to first opioid

The time from catheters placement to the administration of opioids

Time frame: 24 hours postoperatively

Secondary Outcomes

Pain intensity (NRS 0-10/10)

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.

Time frame: 24 hours postoperatively

Total morphine consumption.

Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).

Time frame: 24 hours

Catheter displacement.

Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).

Time frame: 24 hours

Patient satisfaction with application of the catheters.

NRS 0-10/10 during placement of catheters

Time frame: 24 hours

The degree of morphine-related side effects (PONV, itching, fatigue, etc.).

On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe.

Time frame: 24 hours

Time from operation to ambulation.

Data from ClinicalTrials.gov

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