Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- 24h equivalent oral morphine consumption
Study Overview
Brief Summary
Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.
Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.
The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.
The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age of 18 and 65;
- •American Society of Anesthesia (ASA) class II or III
- •elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (T10 dermatome).
Exclusion Criteria
- •preoperative chronic use or contraindication to opioid or NSAID
- •allergy to bupivacaine
- •local skin infection at the injection site of EOI or OSTAP blocks
- •liver or renal insufficiency
- •psychiatric, or neurological disease
- •prior open abdominal surgery above T10 dermatome
- •patients converted to open surgery; and patients expected to be subjected to more tissue trauma.
Arms & Interventions
EOI group
Ultrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
Intervention: External oblique intercostal block (Other)
EOI group
Ultrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
Intervention: Posterior Rectus sheath block (Other)
OSTAP group
Ultrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
Intervention: Oblique subcostal TAP block (Other)
OSTAP group
Ultrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
Intervention: Posterior Rectus sheath block (Other)
Outcomes
Primary Outcomes
24h equivalent oral morphine consumption
Time Frame: 24 hour
Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,
Numerical rating scale (NRS)
Time Frame: 24 hours
Numerical rating scale (NRS) in the PACU, and on arrival to the ward at 0 hours then at 2, 4, 6, 12, and 24 hours postoperatively(NRS) with 0 = no pain, to 100mm = the worst imaginable pain at the specified time.
Secondary Outcomes
- Readiness for discharge(24 hours)
- Quality of recovery 40 score(QoR-40)(24 hours)
- AMBULATION TIME(24 hours)
Investigators
Dr. Mohamed Ibrahim Elsayed
Anesthesia consultant
Al Mashfa Medical Center