External Oblique Intercostal Plane Block for Liver Transplantation Donors

• Sponsor: Istinye University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05890079
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 15.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation; Donor; Postoperative Pain	Other: Subcostal transversus abdominis plane block; Other: External oblique intercostal plane block	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: External Oblique Intercostal Plane Block for Postoperative Analgesia in Living Liver Donors
• Actual Study Start Date: May 8, 2023
• Anticipated Primary Completion Date: Aug 14, 2023
• Anticipated Study Completion Date: Sep 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Subcostal transversus abdominis plane block group 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	Other: Subcostal transversus abdominis plane block; External oblique intercostal plane block will be administered at the end of the surgery and after skin closure.
Active Comparator: External oblique intercostal plane block group 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	Other: External oblique intercostal plane block; External oblique intercostal plane block will be administered at the end of the surgery and after skin closure. .

Outcome Measures

Primary Outcome Measures

1. Morphine consumption [Postoperative 24 hours]

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

Secondary Outcome Measures

1. Postoperative visual analog scale scores [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.

2. Rescue analgesic drug consumption [postoperative 24 hours]

   The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.

3. Incidence of postoperative nausea and vomiting [postoperative 24 hours]

   Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istinye University Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Istinye University

Investigators

• Principal Investigator: Taylan Sahin, M.D., Istinye University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istinye University
• ClinicalTrials.gov Identifier: NCT05890079
• Other Study ID Numbers: anestezi2
• First Posted: Jun 6, 2023
• Last Update Posted: Jun 6, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jun 6, 2023