| CTRI Number |
CTRI/2026/01/100937 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Effect of TAP block on blood pressure and heart rate during laparoscopic removal of uterus. |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided transverse abdominis plane block versus injection dexmeditomidine in maintaining intra-operative hemodynamic stability in total laparoscopic hysterectomy - A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD |
| Address |
DEPARTMENT OF ANAESTHESIA,
MGM MEDICAL COLLEGE AND HOSPITAL,N-6, CIDCO, AURANGABAD (CHHATRAPATI SAMBHAJINAGAR)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9148633325 |
| Fax |
|
| Email |
sudeshkumar8007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANURADHA JOGDAND |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD |
| Address |
DEPARTMENT OF ANAESTHESIA,
MGM MEDICAL COLLEGE AND HOSPITAL, N-6, CIDCO, AURANGABAD (CHHATRAPATI SHAMBHAJINAGAR)
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7710926797 |
| Fax |
|
| Email |
jogdandanuradha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANURADHA JOGDAND |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD |
| Address |
DEPARTMENT OF ANAESTHESIA,
MGM MEDICAL COLLEGE AND HOSPITAL, N-6, CIDCO, AURANGABAD (CHHATRAPATI SHAMBHAJINAGAR)
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7710926797 |
| Fax |
|
| Email |
jogdandanuradha@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital,GM Medical
College,
N-6,CIDCO,
Chhatrapati Sambhajinagar-431003
|
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital Aurangabad |
| Address |
MGM Medical
College,
N-6,CIDCO,
Chhatrapati Sambhajinagar-431003
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sudesh Kumar |
MGM HOSPITAL AURANGABAD |
OPERATION THEATRE No. 1 and 2 (OBSTETRICS AND GYNAECOLOGY OPERATION THEATRE)
Aurangabad
MAHARASHTRA |
914863325
sudeshkumar8007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infusion of injection dexmedetomidine at rate 0.2 to 0.4 micrograms per kg per hour intra operatively |
35 patients will receive infusion injection dexmedetomidine at rate of 0.2 to 0.4 micrograms per kg per hour intra operatively. Patient will be observed from the time of induction to extubation period with duration not more than 4 hour. |
| Intervention |
Ultrasound guided transverse abdominis plane block is given in patients undergoing total laparoscopic surgery |
35 patients will receive ultrasound guided transverse abdominis plane block after anaesthesia induction, using 15 ml of 0.25 percent injection ropivocaine on each side. A linear probe identifies the abdominal muscle layers and the needle is advanced into the fascial plane between the internal oblique and transversus abdominis muscles. after confirming correct placement with a test dose, full drug is injected. Patient will be monitored from the time of block till extubation period not more than 4 hours. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade 1 and 2
2. Elective surgeries
3. Surgeries less than 4 hours |
|
| ExclusionCriteria |
| Details |
1. Patients on beta blocker drugs
2. BMI more than 30
3. Severe cardiac, hepatic and renal diseases
4. patients with Heart block |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic parameters (heart rate and mean arterial blood pressure) between two study groups |
To compare hemodynamic parameters (heart rate and mean arterial blood pressure) between two study groups.These parameters will be monitored before induction, after 5 minutes of induction, at insufflation, at every 15 minutes of surgery, after insufflation and desufflation of pneumoperitoneum and at the time of extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total laparoscopic hysterectomy provides advantages like smaller incisions, reduced postoperative pain, early mobility and shorter hospitalization. However, pneumoperitoneum and the Trendelenburg position still produce significant physiological stress, affecting cardiovascular system and respiratory system. although agents like injection dexmeditomidine are routinely used to control heart rate and blood pressure, the intraoperative hemodynamic benefits of ultrasound guided transverse abdominis plane block remain unclear. The primary objective of this study is to compare transverse abdominis plane block with infusion of injection dexmeditomoidine in maintaining intraoperative hemodynamic stability during total laparoscopic hysterectomy. |