Comparison of the effect of external oblique plane block and transabdominal plane block in acute postoperative pain of living liver donor
Design
The present study is a randomized, double-blind, phase 2-3 clinical trial conducted in a parallel design. A total of 60 patients undergoing liver transplantation will be enrolled in the study. Eligible patients will be randomly assigned to two equal groups, A and B, using a block randomization method.
Settings and conduct
This study will be conducted in the recovery ward. All data will be collected after the surgery is completed by another person who is unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:All liver donors (aged over 18) who are scheduled to undergo left hepatectomy.
Exclusion Criteria: Allergy to the medications used in the study, any contraindications for EOP or TAP blocks, and morbid obesity (body mass index ≥ 40).
Intervention groups
Intervention Group (TAP Group): All patients will receive a standard anesthesia technique for induction. At the end of the surgical procedure, the Transversus Abdominis Plane (TAP) group will receive bilateral TAP blocks under ultrasound guidance, administering 20 milliliters of 0.25% ropivacaine for each block.
Control Group (EOP Group):All patients will receive a standard anesthesia technique for induction. At the end of the surgical procedure, the Erector Spinae Block (EOP) group will receive bilateral EOP blocks under ultrasound guidance, administering 20 milliliters of 0.25% ropivacaine for each block.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121204011662N17
Registration date:2025-03-05, 1403/12/15
Registration timing:prospective
Last update:2025-03-05, 1403/12/15
Update count:0
Registration date
2025-03-05, 1403/12/15
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-01, 1404/01/12
Expected recruitment end date
2025-12-01, 1404/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of external oblique plane block and transabdominal plane block in acute postoperative pain of living liver donor
Public title
Comparison of the Effects of Two Types of Block on Postoperative Pain in Liver Donors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All liver donors (>۱۸ years of age) who will be underwent left hepatectomy
Exclusion criteria:
Allergy to the drugs used in the study
any contraindication for EOP or TAP blocks
morbid obesity (body mass index ≥۴۰)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into 2 groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of 2 groups A and B. In each block, equal numbers for 2 groups will be considered in alternative positions. Then 5 blocks of size 6 will be selected randomly and
patients will be allocated randomly and equally into 2 groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com.
Blinding (investigator's opinion)
Single blinded
Blinding description
Informed consent is obtained from the patient prior to surgery. All data is collected after the surgery by a second person who is unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2024-12-28, 1403/10/08
Ethics committee reference number
IR.SUMS.REC.1403.390
Health conditions studied
1
Description of health condition studied
liver transplantation
ICD-10 code
Y83.0
ICD-10 code description
Surgical operation with transplant of whole organ as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Pain after surgery
Timepoint
At 6, 12, and 24 Hours Post-Operation
Method of measurement
Numerical Rating Scale (NRS)
2
Description
ICU length of stay
Timepoint
After discharge
Method of measurement
Patient history (by day)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (TAP group): All patients will receive a standardized anesthetic technique for induction with ۱۰۰-۲۰۰ mcg fentanyl, ۲-۳ mg/kg propofol, and ۰.۱۵ mg/kg cis-atracurium and ۰.۱ mg/kg morphine. At the end of surgery, transversus abdominis plane (TAP) group will be received ultrasound (US)-guided Bilateral TAP blocks using ۲۰-ml volume of ropivacaine ۰.۲۵% for each.
Category
Treatment - Other
2
Description
Control group(EOP group): All patients will receive a standardized anesthetic technique for induction with ۱۰۰-۲۰۰ mcg fentanyl, ۲-۳ mg/kg propofol, and ۰.۱۵ mg/kg cis-atracurium and ۰.۱ mg/kg morphine. At the end of surgery, texternal oblique plane (EOP) group will be received ultrasound (US)-guided Bilateral EOP blocks using ۲۰-ml volume of ropivacaine ۰.۲۵% for each.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu-Alisina hospital
Full name of responsible person
Fatemeh Khalili
Street address
No. 958, Boostan Blvd, Sadra New City.
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3344 0000
Email
abualisinacharity@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
mohammadi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Khalili
Position
Fellowship of Intra-abdominal organ transplantationAnesthesia