Transversus Abdominis Plane Blocks With and Without Dexamethasone
TAP-DEX
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 7, 2023
November 1, 2023
1.6 years
September 28, 2021
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents.
48 hours
Secondary Outcomes (3)
Opioid consumption in the post-anesthetic care unit (PACU)
48 hours
Length of stay in post-anesthetic care unit (minutes).
60-120 minutes
Length of stay in hospital (days).
3-7 days
Study Arms (2)
Dexamethasone
EXPERIMENTALDexamethasone 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.
Local anesthetic only
NO INTERVENTIONLocal anesthetic (bupivacaine 0.25) 1mL/kg will be used for TAP blocks.
Interventions
Dexamethasone will be added to local anesthetic solution and injected at 4 site for for laparoscopically placed TAP blocks.
Eligibility Criteria
You may qualify if:
- age \> 18
- ASA class I-III
- elective or urgent inpatient laparoscopic/laparoscopic assisted colorectal surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David N Ginther, MD
University of Saskatchewan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 28, 2021
First Posted
June 27, 2022
Study Start
September 1, 2022
Primary Completion
March 31, 2024
Study Completion
August 31, 2024
Last Updated
December 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share