Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

NCT ID: NCT05592522

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2023-02-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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%.

Group Type: EXPERIMENTAL

External oblique intercostal block

Intervention Type: 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 .

Posterior Rectus sheath block

Intervention Type: 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.

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%.

Group Type: EXPERIMENTAL

Oblique subcostal TAP block

Intervention Type: 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.

Posterior Rectus sheath block

Intervention Type: 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.

Interventions

External oblique intercostal block

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 .

Intervention Type: OTHER

Oblique subcostal TAP block

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.

Intervention Type: OTHER

Posterior Rectus sheath block

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.

Intervention Type: OTHER

Other Intervention Names

EOI; OSTAP; PRSB

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al Mashfa Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mohamed Ibrahim Elsayed

Anesthesia consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed I ElSayed

Role: PRINCIPAL_INVESTIGATOR

Al Mashfa Medical Center

Locations

Al Mashfa medical center

Khobar, Eastern Provence, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

1/10-2022

Identifier Type: -

Identifier Source: org_study_id