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NCT Number: NCT05592522

Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Candidate Agnosia Analgesia Narcotic Use Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Mashfa medical center

Khobar, Eastern Provence, 34225/7564, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Other names: EOI

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.

Other names: OSTAP

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.

Other names: PRSB

Primary outcomes

  1. 24h equivalent oral morphine consumption

    Time frame: 24 hour

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

  2. 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

  1. Quality of recovery 40 score(QoR-40)

    Time frame: 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

    Time frame: 24 hours

    Time to first independent ambulation

  3. Readiness for discharge

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Al Mashfa Medical Center

Other

Registry information

Official study title

Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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