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External Oblique Intercostal Plane Block for Liver Transplantation Donors

Primary Purpose

Liver Transplantation, Donor, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Subcostal transversus abdominis plane block
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 Liver Transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 75 years Patients with American Society of Anesthesiology (ASA) physical status I-II Patients scheduled for a living donor hepatectomy Exclusion Criteria: Allergy to local anesthetics Coagulopathy Skin infection at the block area Advanced renal failure Chronic pain syndromes Alcohol or drug abuse Psychiatric disorders

Sites / Locations

  • Istinye University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Subcostal transversus abdominis plane block group

External oblique intercostal plane block group

Arm Description

The patients in subcostal transversus abdominis plane block group will be received subcostal transversus abdominis plane block and patient controlled analgesia with morphine for postoperative analgesia

The patients in External oblique intercostal plane block group will be received external oblique intercostal 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.
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
May 25, 2023
Last Updated
May 25, 2023
Sponsor
Istinye University
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1. Study Identification

Unique Protocol Identification Number
NCT05890079
Brief Title
External Oblique Intercostal Plane Block for Liver Transplantation Donors
Official Title
External Oblique Intercostal Plane Block for Postoperative Analgesia in Living Liver Donors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
September 4, 2023 (Anticipated)

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
Postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. External oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. The aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block and subcostal transversus abdominis plane block in living liver donors. Researchers will compare the external oblique intercostal plane block group with subcostal transversus abdominis plane block to see if the external oblique intercostal plane block is effective for postoperative analgesia in living liver donors.
Detailed Description
Patients scheduled for living donor hepatectomy will be separated into 2 groups: Subcostal Transversus Abdominis Plane Block Group and External Oblique Intercostal Plane Block Group. Patients in Subcostal Transversus Abdominis Plane Block will be performed subcostal transversus plane block at the end of the surgery and after skin closure and 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 at the end of the surgery and after skin closure 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
Liver Transplantation, Donor, Postoperative Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Subcostal transversus abdominis plane block group
Arm Type
Active Comparator
Arm Description
The patients in subcostal transversus abdominis plane block group will be received subcostal transversus abdominis plane block and 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 external oblique intercostal plane block and patient controlled analgesia with morphine for postoperative analgesia
Intervention Type
Other
Intervention Name(s)
Subcostal transversus abdominis plane block
Intervention Description
External oblique intercostal plane block will be administered at the end of the surgery and after skin closure.
Intervention Type
Other
Intervention Name(s)
External oblique intercostal plane block
Intervention Description
External oblique intercostal plane block will be administered at the end of the surgery and after skin closure. .
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
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
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 75 years Patients with American Society of Anesthesiology (ASA) physical status I-II Patients scheduled for a living donor hepatectomy Exclusion Criteria: Allergy to local anesthetics Coagulopathy Skin infection at the block area Advanced renal failure Chronic pain syndromes Alcohol or drug abuse Psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taylan Sahin, M.D.
Phone
+905452303111
Email
taylansah@hotmail.com
Overall Study Officials:
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylan Sahin, M.D.
Phone
+905452303111
Email
taylansah@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

External Oblique Intercostal Plane Block for Liver Transplantation Donors

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