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Continuous TQL Block for Elective Cesarean Section

Z

Zealand University Hospital

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain
Anesthesia, Local

Treatments

Drug: Saline
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03663478
TQL Catheters

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups, including a placebo group

Intervention
Active Comparator group
Description:
Ropivacaine
Treatment:
Drug: Ropivacaine
Control
Placebo Comparator group
Description:
Isotonic saline
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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