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Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

Primary Purpose

Bariatric Surgery Candidate, Pain, Postoperative, Narcotic Use

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
External oblique intercostal block
Oblique subcostal TAP block
Posterior Rectus sheath block
Sponsored by
Al Mashfa Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Al Mashfa medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EOI group

OSTAP group

Arm Description

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%.

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%.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of recovery 40 score(QoR-40)
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
AMBULATION TIME
Time to first independent ambulation
Readiness for discharge
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

Full Information

First Posted
October 19, 2022
Last Updated
February 26, 2023
Sponsor
Al Mashfa Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05592522
Brief Title
Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Mashfa Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Pain, Postoperative, Narcotic Use, Analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EOI group
Arm Type
Experimental
Arm Description
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%.
Arm Title
OSTAP group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
External oblique intercostal block
Other Intervention Name(s)
EOI
Intervention Description
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
Intervention Name(s)
Oblique subcostal TAP block
Other Intervention Name(s)
OSTAP
Intervention Description
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
Intervention Name(s)
Posterior Rectus sheath block
Other Intervention Name(s)
PRSB
Intervention Description
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.
Primary Outcome Measure Information:
Title
24h equivalent oral morphine consumption
Description
Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,
Time Frame
24 hour
Title
Numerical rating scale (NRS)
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Quality of recovery 40 score(QoR-40)
Description
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
Time Frame
24 hours
Title
AMBULATION TIME
Description
Time to first independent ambulation
Time Frame
24 hours
Title
Readiness for discharge
Description
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
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed I ElSayed
Organizational Affiliation
Al Mashfa Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Mashfa medical center
City
Khobar
State/Province
Eastern Provence
ZIP/Postal Code
34225/7564
Country
Saudi Arabia

12. IPD Sharing Statement

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Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

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