Clinical trial NCT05406388: Erector Spinae Plane Block in Liver Transplantation Donors
Official title: Ultrasound-guided Bilateral Erector Spinalis Plane Block on Postoperative Pain Management in Liver Transplantation Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
Primary purpose: TREATMENT

Brief summary: Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.

Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB technique with controls in terms of postoperative opioid consumption and postoperative pain control on donor patients.


Eligibility criteria: Inclusion Criteria:

* Donor patients scheduled for elective hepatectomy in liver transplantation surgery
* ASA I-II
* Patients who are aged between 18-65

Exclusion Criteria:

* Patients who do not accept the procedure
* Skin infection at the site of Erector Spina Plan Block area
* Coagulation disorder or using anticoagulant drugs
* Known local anesthetics and opioid allergy
* Severe pulmonary and/or cardiovascular problems
* Substance addiction or known psychiatric or mental problems
* Chronic painkiller usage
* Pregnancy or lactation

Primary outcomes:
measure: Opioid consumption
timeFrame: Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
Study officials:
affiliation: Medipol University
name: Tumay Uludag Yanaral
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dewe G, Steyaert A, De Kock M, Lois F, Reding R, Forget P. Pain management in living related adult donor hepatectomy: feasibility of an evidence-based protocol in 100 consecutive donors. BMC Res Notes. 2018 Nov 26;11(1):834. doi: 10.1186/s13104-018-3941-1.
citation: Chhibber A, Dziak J, Kolano J, Norton JR, Lustik S. Anesthesia care for adult live donor hepatectomy: our experiences with 100 cases. Liver Transpl. 2007 Apr;13(4):537-42. doi: 10.1002/lt.21074.
citation: Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
citation: El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available.
citation: Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.