The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.

NCT06425484 | Recruiting

• 1 other identifier: USM/JEPeM/kk/23010129
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question\[s\] it aims to answer are:

• what is the pain score for both groups
• what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation. Researchers will compare pain score, epidural infusion requirment between the two groups.

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

• Pain score between epidural plus bilateral TAP block and epidural alone

  To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation.

  Post operatively, until day 2 post operation.

Secondary Outcomes (2)

• To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)

  Post operatively, until day 2 post operation.

• To evaluate time of early mobilization between 2 groups ( Group T and Group E)

  Post operatively, until day 2 post operation.

Study Arms (2)

Group T

EXPERIMENTAL

Group epidural with bilateral US TAP block

Other: Bilateral US TAP block

Group E

ACTIVE COMPARATOR

Group epidural alone

Other: Bilateral US TAP block

Interventions

Bilateral US TAP block OTHER

epidural plus bilateral US guided TAP block

Group E; Group T

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective major laparotomy gynaecology procedure.
• Age 18 years and above
• ASA I, II, III

You may not qualify if:

• Prolonged INR
• Allergic to LA
• History of chronic pain
• Psychological disorder/addict to opioid or benzodiazepine
• Any contraindication for epidural or TAP block procedure
• Pregnancy

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (6)

• Ganapathy S, Sondekoppam RV, Terlecki M, Brookes J, Das Adhikary S, Subramanian L. Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):797-804. doi: 10.1097/EJA.0000000000000345.

  PMID: 26426576 BACKGROUND

• Yoshida T, Furutani K, Watanabe Y, Ohashi N, Baba H. Analgesic efficacy of bilateral continuous transversus abdominis plane blocks using an oblique subcostal approach in patients undergoing laparotomy for gynaecological cancer: a prospective, randomized, triple-blind, placebo-controlled study. Br J Anaesth. 2016 Dec;117(6):812-820. doi: 10.1093/bja/aew339.

  PMID: 27956680 BACKGROUND

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 BACKGROUND

• Iyer SS, Bavishi H, Mohan CV, Kaur N. Comparison of Epidural Analgesia with Transversus Abdominis Plane Analgesia for Postoperative Pain Relief in Patients Undergoing Lower Abdominal Surgery: A Prospective Randomized Study. Anesth Essays Res. 2017 Jul-Sep;11(3):670-675. doi: 10.4103/0259-1162.206856.

  PMID: 28928569 BACKGROUND

• Wu Y, Liu F, Tang H, Wang Q, Chen L, Wu H, Zhang X, Miao J, Zhu M, Hu C, Goldsworthy M, You J, Xu X. The analgesic efficacy of subcostal transversus abdominis plane block compared with thoracic epidural analgesia and intravenous opioid analgesia after radical gastrectomy. Anesth Analg. 2013 Aug;117(2):507-13. doi: 10.1213/ANE.0b013e318297fcee. Epub 2013 Jun 6.

  PMID: 23744953 RESULT

• Huepenbecker SP, Cusworth SE, Kuroki LM, Lu P, Samen CDK, Woolfolk C, Deterding R, Wan L, Helsten DL, Bottros M, Mutch DG, Powell MA, Massad LS, Thaker PH. Continuous epidural infusion in gynecologic oncology patients undergoing exploratory laparotomy: The new standard for decreased postoperative pain and opioid use. Gynecol Oncol. 2019 May;153(2):356-361. doi: 10.1016/j.ygyno.2019.02.017. Epub 2019 Feb 22.

  PMID: 30798950 RESULT

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Munirah Abdul Majid

  University Sains Malaysia

  PRINCIPAL INVESTIGATOR

• W.Mohd Nazaruddin W. Hassan

  University Sains Malaysia

  STUDY DIRECTOR

Central Study Contacts

Rhendra Hardy Mohd Zain

CONTACT

+6097676104; rhendra@gmail.com

Suki Ismet

CONTACT

+6097676105; sukiismet@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: APS team will be assessing participants pain score in the ward and documented the data.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Madya

Model Details: Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T)

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: May 31, 2023
• Primary Completion: May 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)