REduced Pain After Bariatric Surgery - Gastric Bypass (REPABS-BPG)
Overview
- Phase
- Not Applicable
- Intervention
- LG-TAP block with local anesthetic
- Conditions
- Pain
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Pain Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic gastric bypass. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).
Investigators
Vincenzo Bruni
Principal Investigator
Fondazione Policlinico Universitario Campus Bio-Medico
Eligibility Criteria
Inclusion Criteria
- •Elective Laparoscopic Gastric Bypass
- •Body Mass Index (BMI) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
- •BMI \> 40 kg/m², even in the absence of comorbidities
- •ASA physical status score \< 4
Exclusion Criteria
- •ASA physical status score ≥ 4
- •Patient's refusal or inability to sign the informed consent
- •Allergies to any drug provided by the study protocol
Arms & Interventions
LG-TAP
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Local Anesthetic (Ropivacaine Hydrochloride 0.5%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
Intervention: LG-TAP block with local anesthetic
LG-TAP
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Local Anesthetic (Ropivacaine Hydrochloride 0.5%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
Intervention: Port site infiltration
PLACEBO
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
Intervention: Port site infiltration
PLACEBO
The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
Intervention: LG-TAP block with saline solution
Outcomes
Primary Outcomes
Pain Score
Time Frame: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
Secondary Outcomes
- Morphine Consumption(24 hours)
- Ketorolac Consumption(24 hours)
- Nausea and/or Vomiting(48 hours)
- Length of Hospital Stay(72 hours)
- Timt to walking(72 hours)
- Time to first flatus(72 hours)
- Surgical Complications(7 days)