Continuous TQL Block for Elective Cesarean Section

NCT03663478 | Completed Phase 4 DMC

• 1 other identifier: TQL Catheters
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Time to first opioid

  The time from catheters placement to the administration of opioids

  24 hours postoperatively

Secondary Outcomes (6)

• Pain intensity (NRS 0-10/10)

  24 hours postoperatively

• Total morphine consumption.

  24 hours

• Catheter displacement.

  24 hours

• Patient satisfaction with application of the catheters.

  24 hours

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

  24 hours

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Ropivacaine

Drug: Ropivacaine

Control

PLACEBO COMPARATOR

Isotonic saline

Drug: Saline

Interventions

Ropivacaine DRUG

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

Intervention

Saline DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of anaesthesiology

Roskilde, 4000, Denmark

Location

Related Publications (1)

• Steingrimsdottir GE, Hansen CK, Borglum J. Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial. Acta Anaesthesiol Scand. 2020 Sep;64(8):1218-1223. doi: 10.1111/aas.13601. Epub 2020 Apr 22.

  PMID: 32270474 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jens Børglum, MD PhD

  Zealand University Hospital, University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 10, 2018
• Study Start: September 4, 2018
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)