- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233096
Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors
Evaluation of Postoperative Analgesic Efficacy of Ultrasound-Guided Rectus-Intercostal Fascial Plane Block in Living Liver Donors
Postoperative pain control plays a crucial role in enhancing recovery and improving early mobilization in living liver donors. The rectus-intercostal fascial plane (RIFP) block is a novel ultrasound-guided regional anesthesia technique that provides anterior abdominal wall analgesia by targeting the intercostal nerves between the rectus abdominis and intercostal muscle fascia.
This prospective, randomized controlled clinical study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effects of the RIFP block compared with standard intravenous analgesia in living liver donors undergoing donor hepatectomy.
Participants will be randomly assigned to two groups:
Group 1 (RIFP Block): Patients receiving an ultrasound-guided rectus-intercostal fascial plane block using 20 mL of 0.25% bupivacaine at the end of surgery, in addition to standard IV PCA (morphine).
Group 2 (Control): Patients receiving only standard IV PCA (morphine) without regional block.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized controlled study will include living liver donors undergoing donor hepatectomy. Participants will be divided into two groups: the Rectus-Intercostal Fascial Plane (RIFP) Block Group and the Control Group.
In the RIFP group, patients will receive an ultrasound-guided RIFP block at the end of surgery and postoperative analgesia with intravenous morphine PCA. The control group will receive only intravenous morphine PCA without any regional block.
The primary outcome is total morphine consumption during the first 24 postoperative hours.
Secondary outcomes include pain scores at 1, 6, 12, and 24 hours, time to first rescue analgesia, amount of rescue analgesic used, and incidence of postoperative nausea and vomiting.
This study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effect of the RIFP block in living liver donors compared with standard intravenous analgesia.
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:
- 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
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: Rectus Intercostal Plane Block Group
Rectus Intercostal Plane Block Group The patients in the Rectus Intercostal Plane Block group will receive a bilateral rectus intercostal plane block and patient-controlled analgesia (PCA) with morphine for postoperative analgesia.
|
Rectus intercostal plane block will be administered bilaterally at the end of the surgery and after skin closure under ultrasound guidance
|
|
Active Comparator: Control Group
The patients in the Control group will not receive any regional block and will receive PCA with morphine for postoperative analgesia.
|
Ultrasound probe placement on the same region without needle insertion or local anesthetic injection to maintain blinding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine consumption
Time Frame: Postoperative 24 hours
|
The amount of morphine required by the patient and given by the device will be recorded for the first 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
|
|
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
|
|
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
|
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 6
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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