Back to resultsTransversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Transversus Abdominis Plane Block
standard general anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring transversus abdominis plane block, living liver transplantation, postoperative analgesia
Eligibility Criteria
Inclusion Criteria:
- Liver transplantation donors
Exclusion Criteria:
- Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
transversus abdominis plane block
nonblocked
Arm Description
Patients who received a tranversus abdominis plane block with ultrasound after standard general anesthesia represented Group 1. The tranversus abdominis plane block was performed bilaterally by obtaining an image with real time ultrasound guidance with a 6-13 MHz linear probe. The block was placed with a 22 G 80 mm needle while obtaining real-time images via an in-plane technique. Two 20 mL syringes were prepared after preparing a local anesthetic concentration of 1.5 mg/kg of 0.5% bupivacaine to 40 mL with saline. These were administered to the left and right abdominal walls. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.
Patients who received standard general anesthesia alone made up Group 2. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.
Outcomes
Primary Outcome Measures
pain scores (at movement and at rest)
Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).
Secondary Outcome Measures
morphine consumption
morphine consumption were measured in postoperatively 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02645903
Brief Title
Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
Official Title
Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy: Randomized Controlled Double-blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.
Detailed Description
This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
transversus abdominis plane block, living liver transplantation, postoperative analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
Patients who received a tranversus abdominis plane block with ultrasound after standard general anesthesia represented Group 1.
The tranversus abdominis plane block was performed bilaterally by obtaining an image with real time ultrasound guidance with a 6-13 MHz linear probe.
The block was placed with a 22 G 80 mm needle while obtaining real-time images via an in-plane technique.
Two 20 mL syringes were prepared after preparing a local anesthetic concentration of 1.5 mg/kg of 0.5% bupivacaine to 40 mL with saline. These were administered to the left and right abdominal walls.
Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.
Arm Title
nonblocked
Arm Type
Placebo Comparator
Arm Description
Patients who received standard general anesthesia alone made up Group 2. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.
Intervention Type
Drug
Intervention Name(s)
Transversus Abdominis Plane Block
Other Intervention Name(s)
Marcaine plain+morphine
Intervention Description
Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1
Intervention Type
Drug
Intervention Name(s)
standard general anesthesia
Other Intervention Name(s)
morphine
Intervention Description
Cases to whom applied alone standard general anesthesia were determined as Group 2
Primary Outcome Measure Information:
Title
pain scores (at movement and at rest)
Description
Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).
Time Frame
postoperatively at 24 hours
Secondary Outcome Measure Information:
Title
morphine consumption
Description
morphine consumption were measured in postoperatively 24 hours
Time Frame
postoperatively at 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver transplantation donors
Exclusion Criteria:
Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Ali Erdogan
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22286518
Citation
Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
Results Reference
result
Learn more about this trial
Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
We'll reach out to this number within 24 hrs