Gynecologic DiseaseNCT06425484
The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.
A study testing Bilateral US TAP block in people with Gynecologic Disease, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Bilateral US TAP block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteMalaysia
- Study dates
- 31 May 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective major laparotomy gynaecology procedure.
- Age 18 years and above
- ASA I, II, III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Munirah Abdul Majid, +6097673000, munirah.amajid@gmail.com
Suki Ismet, +6097676105, sukiismet@usm.my
About this study
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.
Read the detailed description
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.
- Conditions
- Gynecologic Disease
- Being tested
- Bilateral US TAP block
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral US TAP blockOther
epidural plus bilateral US guided TAP block
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Group epidural with bilateral US TAP block Receives: Other: Bilateral US TAP block |
| Group E | Active comparator | Group epidural alone Receives: Other: Bilateral US TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone.
Measured: Post operatively, until day 2 post operation.
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 .
Measured: Post operatively, until day 2 post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start31 May 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia
- Investigators
- Munirah Abdul Majid, Principal investigator, University Sains MalaysiaW.Mohd Nazaruddin W. Hassan, Study director, University Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425484
- Sponsor's protocol ID
- USM/JEPeM/kk/23010129
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26426576Yoshida 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.
PubMed 27956680Tsai 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.
PubMed 29226150Iyer 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.
PubMed 28928569Wu 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.
PubMed 23744953Huepenbecker 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.
PubMed 30798950
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.
- ClinicalTrials.gov ID
- NCT06425484
- Acronym / sponsor ID
- USM/JEPeM/kk/23010129
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T)
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Other: Bilateral US TAP blockGroup epidural with bilateral US TAP block |
| Group E | Active comparator | Other: Bilateral US TAP blockGroup epidural alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective major laparotomy gynaecology procedure.
- Age 18 years and above
- ASA I, II, III
Key exclusion criteria (6 listed)
- Prolonged INR
- Allergic to LA
- History of chronic pain
- Psychological disorder/addict to opioid or benzodiazepine
- Any contraindication for epidural or TAP block procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral US TAP blockepidural plus bilateral US guided TAP block | Other | Group E, Group T |
Primary outcome
Pain score between epidural plus bilateral TAP block and epidural alone
Time frame: Post operatively, until day 2 post operation.
To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation.
2 secondary outcomes
To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)
Time frame: Post operatively, until day 2 post operation.
To evaluate time of early mobilization between 2 groups ( Group T and Group E)
Time frame: Post operatively, until day 2 post operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 26426576Ganapathy 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.
- Background: PubMed 27956680Yoshida 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.
- Background: PubMed 29226150Tsai 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.
- Background: PubMed 28928569Iyer 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.
- Results publication: PubMed 23744953Wu 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.
- Results publication: PubMed 30798950Huepenbecker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munirah Abdul Majid principal investigator
University Sains Malaysia
W.Mohd Nazaruddin W. Hassan study director
University Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral US TAP block in people with Gynecologic Disease, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rhendra Hardy Mohd Zain (+6097676104, rhendra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score between epidural plus bilateral TAP block and epidural alone (time frame: Post operatively, until day 2 post operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425484, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.