Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

NCT05592522 | Completed

• 1 other identifier: 1/10-2022
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Pain, Postoperative; Narcotic Use; Analgesia

Outcome Measures

Primary Outcomes (2)

• 24h equivalent oral morphine consumption

  Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,

  24 hour

• Numerical rating scale (NRS)

  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.

  24 hours

Secondary Outcomes (3)

• Quality of recovery 40 score(QoR-40)

  24 hours

• AMBULATION TIME

  24 hours

• Readiness for discharge

  24 hours

Study Arms (2)

EOI group

EXPERIMENTAL

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%.

Other: External oblique intercostal block; Other: Posterior Rectus sheath block

OSTAP group

EXPERIMENTAL

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%.

Other: Oblique subcostal TAP block; Other: Posterior Rectus sheath block

Interventions

External oblique intercostal block OTHER

EOI block:Under guidance of the linear high frequency transducer, sagittal plane between anterior axillary line and midclavicular line at the level of the 6th rib, In-plane approach between external oblique and intercostal muscles Hydrodissection with 30 ml of 0.25% bupivacaine hydrochloride .

Also known as: EOI

EOI group

Oblique subcostal TAP block OTHER

OSTAP block: The needle was inserted in plane through the rectus adjacent to costal margin Once the tip of the needle was visualized in between the rectus muscle and transversus abdominus muscle and negative pressure aspiration was demonstrated, 30 ml bupivacaine 0.25% was deposited within the plane and hydrodissection was noted.

Also known as: OSTAP

OSTAP group

Posterior Rectus sheath block OTHER

Posterior rectus sheath block: Under linear ultrasound probe, the needle was advanced gradually through the rectus muscle posteriorly toward its medial edge, approaching the rectus sheath. After negative aspiration,12.5 mL bupivacaine 0.25% was injected until the rectus muscle was separated from the posterior rectus sheath by hydrodissection.

Also known as: PRSB

EOI group; OSTAP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Mashfa Medical Center: lead

Study Sites (1)

Al Mashfa medical center

Khobar, Eastern Provence, 34225/7564, Saudi Arabia

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Mohamed I ElSayed

  Al Mashfa Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia consultant

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: October 26, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

SA (1)