Gynecologic Disease Clinical Trial
Official title:
The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | August 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Elective major laparotomy gynaecology procedure. - Age 18 years and above - ASA I, II, III Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Sains Malaysia | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia |
Malaysia,
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. — View Citation
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: Th — View Citation
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. — View Citation
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. — View Citation
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 rad — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | To evaluate time of early mobilization between 2 groups ( Group T and Group E) | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05509244 -
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
|
N/A | |
Recruiting |
NCT04963751 -
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
|
N/A | |
Recruiting |
NCT05125692 -
Vaginal Repair of Post Cesarean Istmocele
|
N/A | |
Active, not recruiting |
NCT04171297 -
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
|
||
Completed |
NCT06011928 -
MOPEXE and RE in Treating Dysmenorrhea
|
N/A | |
Not yet recruiting |
NCT05974995 -
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
|
N/A | |
Completed |
NCT04839263 -
Fast-track in Minimally Invasive Gynaecology
|
N/A | |
Completed |
NCT04498208 -
Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery
|
N/A | |
Completed |
NCT04642118 -
Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery
|
N/A | |
Completed |
NCT03820115 -
Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions
|
N/A | |
Recruiting |
NCT03327506 -
Preoperative Hypnosis Versus Premedication in Gynecological Surgery
|
Phase 4 | |
Recruiting |
NCT02957500 -
To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
|
N/A | |
Completed |
NCT02476799 -
Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery
|
N/A | |
Completed |
NCT02450084 -
Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
|
N/A | |
Completed |
NCT03916445 -
Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases
|
||
Completed |
NCT05325619 -
Evaluation of the Rate of Consultations in Gynecological Emergencies Under "Non-urgent" Management
|
||
Not yet recruiting |
NCT05781581 -
A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection
|
||
Recruiting |
NCT03427840 -
Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
|
||
Completed |
NCT03884244 -
Postoperative Chewing Gum and Gynecological Laparoscopic Surgery
|
N/A | |
Completed |
NCT05428982 -
The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial
|
N/A |