The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure: A Randomized Single Blinded Placebo Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- visual analogue scale (VAS) scores
Study Overview
Brief Summary
Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain management is a challenging issue. In this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.
Detailed Description
TAP block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. In that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients between 18-65
- •undergo Laparoscopic sleeve gastrectomy
Exclusion Criteria
- •Bupivacaine allergy
- •having chronic pain or taking pain management
- •ASA ( The American Society of Anesthesiologists Physical Classification System) Class 4 or
- •Patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair
Arms & Interventions
TAP Block
In this group ,TAP block will be performed with 0.5% 15 ml bupivacaine + 5 ml .
Intervention: Transversus abdominis plane block (Procedure)
Placebo
In this group , 20 ml saline solution will injected into the transversus abdominis plane.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
visual analogue scale (VAS) scores
Time Frame: 24th ours
VAS scores of the patients within 24 hours postoperatively minimun:0 maximum:10
postoperative analgesia doses
Time Frame: within 24 hours postoperatively
totally consumed analgesics
Secondary Outcomes
- Nausea and vomiting score(within 24 hours postoperatively)
- first mobilization and flatus time(within 24 hours postoperatively)
- time of first opioid administration(within 24 hours postoperatively)
Investigators
Sonmez Ocak
Sonmez Ocak,MD, Chief of residents
Samsun Education and Research Hospital