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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:
Researchers will compare pain score, epidural infusion requirment between the two groups.
The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively.
Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block.
Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs.
The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T | Experimental | Group epidural with bilateral US TAP block |
|
| Group E | Active Comparator | Group epidural alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral US TAP block | Other | epidural plus bilateral US guided TAP block |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the epidural infusion requirement between the 2 groups ( Group T and Group E) | To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone. | Post operatively, until day 2 post operation. |
| To evaluate time of early mobilization between 2 groups ( Group T and Group E) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rhendra Hardy Mohd Zain | Contact | +6097676104 | rhendra@gmail.com | |
| Suki Ismet | Contact | +6097676105 | sukiismet@usm.my |
| Name | Affiliation | Role |
|---|---|---|
| Munirah Abdul Majid | University Sains Malaysia | Principal Investigator |
| W.Mohd Nazaruddin W. Hassan | University Sains Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Sains Malaysia | Recruiting | Kubang Kerian | Kelantan | 16150 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26426576 | Background | 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. | |
| 27956680 |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T)
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APS team will be assessing participants pain score in the ward and documented the data.
To evaluate time taken for early mobilization between group Epidural with TAP block and epidural alone after the operation . |
| Post operatively, until day 2 post operation. |
| 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. |
| 29226150 | 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. |
| 28928569 | 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. |
| 23744953 | Result | 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. |
| 30798950 | 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. |