NCT04151511

Brief Summary

Introduction Adult living related donor hepatectomy is associated with pain due to the sub-costal j-shaped incision, rib retraction using Thompson retractor, and diaphragm irritation1. The incidence of severe pain after donor hepatectomy is 11 to 37%2. Therefore adequate analgesia is important for optimum perioperative safety profiles and speedy recovery. Poor pain management is associated with risk of atelectasis, respiratory failure, and delayed discharge from the hospital. so this study is comparison of two technique (Thoracic epidural analgesia vs Erector spinae plane block) to relieve pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

October 22, 2019

Last Update Submit

November 2, 2019

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain scores

    Post-operative pain scores using the visual analog scale (V.A.S) 0-10 for pain at rest and at maximal inspiration during the post-operative period at PACU. 0 means no pain and 10 means unbearable pain. Higher scores would be worse outcome. primary outcome post-operative pain scores measured at 6 hours.

    6 hour

Secondary Outcomes (1)

  • The dosage of adjunct nalbuphine used (mg)

    6 hour

Study Arms (2)

Continuous Thoracic Epidural

OTHER

Continuous Thoracic Epidural Analgesia for Postoperative Analgesia in Patients Undergoing Adult Living Donar Open Hepatectomies

Procedure: Continuous Erector Spinae Plane Block

Continuous Erector Spinae Plane Block

EXPERIMENTAL

Continuous Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Adult Living Donar Open Hepatectomies

Procedure: Continuous Erector Spinae Plane Block

Interventions

Continuous Erector Spinae Plane BlockPROCEDURE

1. Continuous Thoracic Epidural Thoracic Epidural Analgesia 2. Continuous Erector Spinae Plane Block

Continuous Erector Spinae Plane BlockContinuous Thoracic Epidural

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age

You may not qualify if:

  • Neurological impairment
  • Allergy, hypersensitivity or any other contraindications to local anesthetic
  • Anatomical variation for block landmarks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital

Islamabad, 44000, Pakistan

RECRUITING

Related Publications (12)

  • Kostov S, Schug SA. Depression and chronic pain. Saudi J Anaesth. 2018 Jul-Sep;12(3):377-378. doi: 10.4103/sja.SJA_69_18. No abstract available.

    PMID: 30100833RESULT

  • 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.

    PMID: 30477577RESULT

  • Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191.

    PMID: 23662750RESULT

  • 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.

    PMID: 17394151RESULT

  • 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.

    PMID: 28188611RESULT

  • 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.

    PMID: 30292068RESULT

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016RESULT

  • Jain K, Jaiswal V, Puri A. Erector spinae plane block: Relatively new block on horizon with a wide spectrum of application - A case series. Indian J Anaesth. 2018 Oct;62(10):809-813. doi: 10.4103/ija.IJA_263_18.

    PMID: 30443066RESULT

  • Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17.

    PMID: 29416155RESULT

  • Tulgar S, Selvi O, Kapakli MS. Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol. 2018 Feb 18;2018:3947281. doi: 10.1155/2018/3947281. eCollection 2018.

    PMID: 29670771RESULT

  • De Pietri L, Siniscalchi A, Reggiani A, Masetti M, Begliomini B, Gazzi M, Gerunda GE, Pasetto A. The use of intrathecal morphine for postoperative pain relief after liver resection: a comparison with epidural analgesia. Anesth Analg. 2006 Apr;102(4):1157-63. doi: 10.1213/01.ane.0000198567.85040.ce.

    PMID: 16551916RESULT

  • Zubair M, Adil Khan M, Khan MNA, Iqbal S, Ashraf M, Saleem SA. Comparison of Continuous Thoracic Epidural With Erector Spinae Block for Postoperative Analgesia in Adult Living Donor Hepatectomy. Cureus. 2022 Mar 14;14(3):e23151. doi: 10.7759/cureus.23151. eCollection 2022 Mar.

    PMID: 35444875DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Dr Muhammad Zubair

    Shifa International Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Muhammad Zubair

CONTACT

00923335317056zubair831@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant Anaesthesiology

Study Record Dates

First Submitted

October 22, 2019

First Posted

November 5, 2019

Study Start

October 19, 2019

Primary Completion

March 1, 2020

Study Completion

October 1, 2020

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations

PA(1)