- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233083
External Oblique Intercostal Plane Block for Liver Transplantation Recipient
External Oblique Intercostal Plane Block for Postoperative Analgesia in Liver Transplantation
Postoperative pain management is one of the key factors in improving rehabilitation and accelerating recovery. The external oblique intercostal plane block can be used to provide abdominal wall analgesia for effective pain control in abdominal surgery.
The aim of this study is to investigate the postoperative analgesic efficacy of the external oblique intercostal plane block in liver transplant recipients.
The investigators will compare a group receiving the external oblique intercostal plane block with a control group to determine whether this block provides effective postoperative analgesia in liver transplant recipients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients scheduled for liver transplantation will be separated into 2 groups: External Oblique Intercostal Plane Block Group and Control Group.
Patients in the 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 will receive patient controlled analgesia with morphine for postoperative analgesia.
Patients in the Control Group will not receive any block procedure and will receive patient controlled analgesia with morphine for postoperative analgesia.
Morphine consumption for first postoperative 48 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting, and Quality of Recovery-15 scores will be recorded.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Taylan Sahin
- Phone Number: +905452303111
- Email: taylansah@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Istinye University
-
Contact:
- Taylan Sahin
- Phone Number: 905452303111
- Email: taylansah@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 to 75 years
- Scheduled for elective orthotopic liver transplantation (living or deceased donor)
- J-shaped or Mercedes incision planned
- ASA physical status III-IV
- Normal or acceptable coagulation profile at the time of block application (INR ≤ 1.5, platelet count ≥ 50,000/mm³, fibrinogen ≥ 150 mg/dL)
- Able to provide written informed consent
Exclusion Criteria:
- Coagulopathy at the time of block application (INR > 1.5, platelet count < 50,000/mm³, or fibrinogen < 150 mg/dL)
- Known allergy or hypersensitivity to local anesthetics (amide group)
- Local infection or skin lesion at the block injection site
- Severe hemodynamic instability requiring high-dose vasopressor support
- Chronic opioid use (≥30 mg oral morphine equivalents per day for ≥30 days before surgery)
- Severe hepatic encephalopathy or cognitive impairment preventing use of PCA or pain scoring
- Emergency or re-transplantation surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: External oblique intercostal plane block group
The patients in the External Oblique Intercostal Plane Block group will receive bilateral external oblique intercostal plane block and patient controlled analgesia (PCA) with morphine for postoperative analgesia.
|
External oblique intercostal plane block will be administered at the end of the surgery and after skin closure
|
|
Sham Comparator: Control Group
The patients in the Control group will not receive any regional block and will receive patient controlled analgesia (PCA) with morphine for postoperative analgesia.
|
Sham Block (Ultrasound probe placement without needle insertion or injection)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative visual analog scale scores
Time Frame: Postoperative 24 hours
|
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.
|
Postoperative 24 hours
|
|
Incidence of postoperative nausea and vomiting
Time Frame: postoperative 24 hours
|
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
|
postoperative 24 hours
|
|
Rescue analgesic drug consumption
Time Frame: postoperative 24 hours
|
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours
|
postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- anestezi 5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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