## Protocol Section
### Identification Module
**NCT ID:** NCT06425484

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

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

#### Organization Study ID Info
**ID:** USM/JEPeM/kk/23010129
#### Organization
**Class:** OTHER
**Full Name:** Universiti Sains Malaysia
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-31

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universiti Sains Malaysia

#### Responsible Party

**Investigator Affiliation:** Universiti Sains Malaysia

**Investigator Full Name:** Rhendra Hardy Mohamad Zaini

**Investigator Title:** Prof Madya

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Gynecologic Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** SINGLE

**Masking Description:** APS team will be assessing participants pain score in the ward and documented the data.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 46

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group epidural with bilateral US TAP block

**Intervention Names:**

- Other: Bilateral US TAP block

**Label:** Group T

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Group epidural alone

**Intervention Names:**

- Other: Bilateral US TAP block

**Label:** Group E

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group E

- Group T

**Description:** epidural plus bilateral US guided TAP block

**Name:** Bilateral US TAP block

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Pain score between epidural plus bilateral TAP block and epidural alone

**Time Frame:** Post operatively, until day 2 post operation.

#### Secondary Outcomes

**Description:** To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone.

**Measure:** To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)

**Time Frame:** Post operatively, until day 2 post operation.

**Description:** To evaluate time taken for early mobilization between group Epidural with TAP block and epidural alone after the operation .

**Measure:** To evaluate time of early mobilization between 2 groups ( Group T and Group E)

**Time Frame:** Post operatively, until day 2 post operation.

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rhendra@gmail.com

**Name:** Rhendra Hardy Mohd Zain

**Phone:** +6097676104

**Role:** CONTACT

**Contact 2:**

**Email:** sukiismet@usm.my

**Name:** Suki Ismet

**Phone:** +6097676105

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kubang Kerian

**Contacts:**

***Contact 1:***

- **Email:** munirah.amajid@gmail.com

- **Name:** Munirah Abdul Majid

- **Phone:** +6097673000

- **Role:** CONTACT

***Contact 2:***

- **Email:** sukiismet@usm.my

- **Name:** Suki Ismet

- **Phone:** +6097676105

- **Role:** CONTACT

**Country:** Malaysia

**Facility:** Universiti Sains Malaysia

**State:** Kelantan

**Status:** RECRUITING

**Zip:** 16150

#### Overall Officials

**Official 1:**

**Affiliation:** University Sains Malaysia

**Name:** Munirah Abdul Majid

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University Sains Malaysia

**Name:** W.Mohd Nazaruddin W. Hassan

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**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.

**PMID:** 27956680

**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.

**PMID:** 29226150

**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.

**PMID:** 28928569

**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 radical gastrectomy. Anesth Analg. 2013 Aug;117(2):507-13. doi: 10.1213/ANE.0b013e318297fcee. Epub 2013 Jun 6.

**PMID:** 23744953

**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: 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: HIGH

- As Found: Gynecologic Disease

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005831

- Term: Genital Diseases, Female

### Misc Info Module

- Version Holder: 2024-05-31
