Recruiting
Phase 1
Phase 2

Transversus Abdominis Plane Blocks with Dexamethasone

Sponsor:

University of Saskatchewan

Code:

NCT05432934

Conditions

Colorectal Disorders

Regional Anesthesia Morbidity

Analgesia

Local Anesthetic Complication

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dexamethasone

Study Details

Brief summary:

Dexamethasone will be used as an adjunct to local anesthetics (bupivacaine) to prolong the duration of laparoscopically-placed transversus-abdominis plane blocks in elective colorectal resection.

Conditions

Colorectal Disorders

Regional Anesthesia Morbidity

Analgesia

Local Anesthetic Complication

Pain, Postoperative

Study ID

NCT05432934

Start date

Sep 1, 2022

Status verified date

Nov, 2023

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • age > 18
  • ASA class I-III
  • elective or urgent inpatient laparoscopic/laparoscopic assisted colorectal surgery.

Exclusion Criteria:

  • emergency surgery
  • open surgery
  • contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum)
  • ASA class 4
  • age < 18
  • pregnant or breastfeeding women
  • significant cardiorespiratory/hepatic/renal disease
  • allergy to any study drugs
  • inability to consent
  • inability to respond to pain assessments
  • inability to use the patient-controlled analgesia device (PCA)
  • preoperative chronic opioid use

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dexamethasone

Dexamethasone 16mg will be added to local anesthetic solution for TAP blocks. 4mg will be injected at 4 anterior abdominal wall sites in a laparoscopically-administered TAP block. This is a single intraoperative dose.

no intervention: Local anesthetic only

Local anesthetic (bupivacaine 0.25) 1mL/kg will be used for TAP blocks.

Interventions

Dexamethasone

Dexamethasone will be added to local anesthetic solution and injected at 4 site for for laparoscopically placed TAP blocks.

Primary outcome measure

  • Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents. [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

David N Ginther, MD

306-655-6893n.ginther@usask.ca

Locations

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

David Ginther, MD

3066556893n.ginther@usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

Dec 7, 2023

Last verified

Nov, 2023

Keywords

  • perioperative analgesia
  • TAP block
  • laparoscopic surgery
  • regional anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2023-12-07.