Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

Sponsor
Al Mashfa Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05592522
Collaborator
(none)
80
1
2
5.2
15.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: External oblique intercostal block
  • Other: Oblique subcostal TAP block
  • Other: Posterior Rectus sheath block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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%.

Other: 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 .
Other Names:
  • EOI
  • 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.
    Other Names:
  • PRSB
  • Experimental: 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%.

    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.
    Other Names:
  • OSTAP
  • 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.
    Other Names:
  • PRSB
  • Outcome Measures

    Primary Outcome Measures

    1. 24h equivalent oral morphine consumption [24 hour]

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

    2. Numerical rating scale (NRS) [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 Outcome Measures

    1. Quality of recovery 40 score(QoR-40) [24 hours]

      Quality of recovery 40 score at 24 hours.Twelve questions measured the comfort state; 9 questions measured the emotional state; 7 questions measured the psychological state; 5 questions measured the physical independence and 7 questions measured the level of pain. Each question received a score of 1 to 5 with a worst possible score of 40 and a best possible score of 200

    2. AMBULATION TIME [24 hours]

      Time to first independent ambulation

    3. Readiness for discharge [24 hours]

      time to readiness for discharge were measured according to the modified postoperative discharge scoring system (PADSS). Patients were considered eligible for discharge if they achieved a total score ≥ 9 on the condition that the vital signs parameter score was not less than 2, and none of the other five parameters scored a zero

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al Mashfa medical center Khobar Eastern Provence Saudi Arabia 34225/7564

    Sponsors and Collaborators

    • Al Mashfa Medical Center

    Investigators

    • Principal Investigator: Mohamed I ElSayed, Al Mashfa Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Mohamed Ibrahim Elsayed, Anesthesia consultant, Al Mashfa Medical Center
    ClinicalTrials.gov Identifier:
    NCT05592522
    Other Study ID Numbers:
    • 1/10-2022
    First Posted:
    Oct 24, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2022