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Completed

NCT Number: NCT03663478

Continuous TQL Block for Elective Cesarean Section

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of anaesthesiology

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Drug

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

Saline

Drug

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

Primary outcomes

  1. Time to first opioid

    Time frame: 24 hours postoperatively

    The time from catheters placement to the administration of opioids

Secondary outcomes

  1. Pain intensity (NRS 0-10/10)

    Time frame: 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.

  2. Total morphine consumption.

    Time frame: 24 hours

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

  3. Catheter displacement.

    Time frame: 24 hours

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

  4. Patient satisfaction with application of the catheters.

    Time frame: 24 hours

    NRS 0-10/10 during placement of catheters

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

    Time frame: 24 hours

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

  6. Time from operation to ambulation.

    Time frame: 24 hours

    Time from operation to ambulation.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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