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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06324942
Other study ID # REB24-0349
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2026

Study information

Verified date March 2024
Source University of Calgary
Contact Stephen Wood, MD
Phone 4039441438
Email slwood@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital.


Description:

Randomized clinical trial of Transversus Abdominis Plane Block (TAP block) at Cesarean Section.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 2026
Est. primary completion date June 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - ASA status II to III - All patients undergoing elective CS under regional anesthesia at any gestational age. Exclusion Criteria: - - Known drug allergy to local anesthetics - Planned general anesthetic - NSAID use contraindicated post partum - Chronic pain disorder or chronic narcotic use/dependence - Planned vertical abdominal incision - Planned Cesarean Hysterectomy. - Placenta Previa or suspected Placenta Accreta

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg
Surgeon-administered Transversus Abdominis Plane Block

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post operative Pain VAS scale 0-no pain to 10-worst pain 12 hours post op
Secondary Time to first request for rescue analgesia in hours Time from completion of surgery to first request for rescue analgesia in hours 48 hours post op
Secondary Post operative Opioid use Total opioid consumption in the first 24h and 48h mark, postoperatively up to 48 hours post op.
Secondary Time from surgery to discharge from hospital Time from completion of surgery to discharge Up to discharge from hospital, usually 1-3 days
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