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External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

Primary Purpose

Obesity, Analgesia, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intravenous morphine patient control device
External oblique intercostal plane block
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 80 years Patients with American Society of Anesthesiology (ASA) physical status II-III Patients scheduled for a laparoscopic sleeve gastrectomy Exclusion Criteria: Allergy to local anesthetics Coagulopathy Skin infection at the EOI Plane Block area Advanced hepatic or renal failure Chronic pain syndromes Alcohol or drug abuse Severe pulmonary and/or cardiovascular disease Psychiatric disorders

Sites / Locations

  • Istinye University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

External oblique intercostal plane block group

Arm Description

The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia

The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia

Outcomes

Primary Outcome Measures

Morphine consumption
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.

Secondary Outcome Measures

Postoperative visual analog scale scores
Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Time to first rescue analgesic
The time for administration of first rescue analgesic will be recorded.
Rescue analgesic drug consumption
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Incidence of postoperative nausea and vomiting
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours

Full Information

First Posted
December 15, 2022
Last Updated
May 25, 2023
Sponsor
Istinye University
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1. Study Identification

Unique Protocol Identification Number
NCT05663658
Brief Title
External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy
Official Title
External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istinye University

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
The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy. Researchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.
Detailed Description
Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Analgesia, Postoperative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia
Arm Title
External oblique intercostal plane block group
Arm Type
Active Comparator
Arm Description
The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia
Intervention Type
Other
Intervention Name(s)
Intravenous morphine patient control device
Intervention Description
24-hour morphine consumption will be recorded
Intervention Type
Other
Intervention Name(s)
External oblique intercostal plane block
Intervention Description
External oblique intercostal plane block will be administered before the surgery.
Primary Outcome Measure Information:
Title
Morphine consumption
Description
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Postoperative visual analog scale scores
Description
Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Time Frame
Postoperative 24 hours
Title
Time to first rescue analgesic
Description
The time for administration of first rescue analgesic will be recorded.
Time Frame
postoperative 24 hours
Title
Rescue analgesic drug consumption
Description
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Time Frame
postoperative 24 hours
Title
Incidence of postoperative nausea and vomiting
Description
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
Time Frame
postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 80 years Patients with American Society of Anesthesiology (ASA) physical status II-III Patients scheduled for a laparoscopic sleeve gastrectomy Exclusion Criteria: Allergy to local anesthetics Coagulopathy Skin infection at the EOI Plane Block area Advanced hepatic or renal failure Chronic pain syndromes Alcohol or drug abuse Severe pulmonary and/or cardiovascular disease Psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Sait Kavakli, M.D.
Organizational Affiliation
Istinye University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taylan Sahin, M.D.
Organizational Affiliation
Istinye University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istinye University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy

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