| CTRI Number |
CTRI/2024/11/076137 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparative study of two different types of regional block for postoperative analgesia in uterus removal surgery |
|
Scientific Title of Study
|
comparison of erector spinae plane block and quadratus lumborum block for postoperative analgesia in total abdominal hysterectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmee Vijay Chavan |
| Designation |
Professor |
| Affiliation |
D Y Patil Medical College, Kolhapur |
| Address |
Department of Anaesthesia , First Floor
D Y Patil Medical college Hospital
Kadamwadi
Kolhapur 416003
D Y Patil Medical College
Kadamwadi, Kolhapur
416003
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9823243848 |
| Fax |
|
| Email |
rashmeevchavan@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmee Vijay Chavan |
| Designation |
Professor |
| Affiliation |
D Y Patil Medical College, Kolhapur |
| Address |
602, Vastushree Vrindavan Shivaji Park .
Kolhapur
Maharashtra
416003
D Y Patil Medical College
Kadamwadi, Kolhapur
416003
MAHARASHTRA
416003
India |
| Phone |
9823243848 |
| Fax |
|
| Email |
rashmeevchavan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmee Vijay Chavan |
| Designation |
Professor |
| Affiliation |
D Y Patil Medical College, Kolhapur |
| Address |
Department of Anaesthesiology
First Floor
D Y Patil Medical College Kolhapur
Maharashtra
D Y Patil Medical College
Kadamwadi, Kolhapur
416003
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9823243848 |
| Fax |
|
| Email |
rashmeevchavan@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil Medical College
Kadamwadi,
Kolhapur, Maharashtra
416003
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Rashmee Vijay Chavan |
| Address |
Department of Anaesthesiology, First Floor, D Y Patil Medical College , Kolhapur
Maharashtr
416003 |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Rashmee Vijay Chavan |
D Y Patil Medical College Hospital |
Department of Anaesthesiology
First Floor
D Y Patil Medical College
Kadamwadi, Kolhapur
Maharashtra
416003
Kadamwadi
Kolhapur
Kolhapur
MAHARASHTRA |
9823243848
rashmeevchavan@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, D Y Patil Medical College, Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
B/ L USG guided Erector Spinae Plane BLock |
Patients in Group B will receive USG guided Erector spinae Plane Block in lateral position. 20 cc of 0.25% Bupivacaine will be injected on each side . Later hysterectomy procedure will be carried out as routine under general anaesthesia |
| Intervention |
B/L USG guided Quadratus Lumborum Plane Block will be
given in Group A
|
Patients in Group A will receive quadratus lumborum block with USG in lateral position and 20 cc of 0.25% Bupivacaine will be injected on each side. Later procedure will be carried out as routine under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients age group between 30-65 yrs
2. Patients undergoing elective abdominal hysterectomy surgery
3. ASA I-III
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study
2. Patients with allergy to local anaesthetic
3.Patients with coagulopathy
4.Patients with cancer pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for first analgesic requirement will be noted . |
Time for first analgesic requirement will be noted in post operative period . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of ambulation
Time to get up in bed and sit
Time to walk |
for first two days in postoperative period |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 1 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
44 patients posted for elective abdominal hysterectomy will be selected for the study. they will be divided by computer generated ramdom number method in two equal groups of 22 each. Group A will receive usg guided Quadratus lumborum block.bilateraly in lateral position before operation with 20 cc of 0.25% of bupivacaine on each side. Time of block placement will be noted. Similarly Group B will receive Usg Guided Erector Spinae Plane Block bilateraly in lateral position before operation with 20 cc 0.25% bupivacaine on each side and time of block placement will be noted. Abdominal hysterectomy will be carried out as per routine procedure under general anaesthesia and surgical duration will be noted . In postoperative period patients will be observed for 24 hrs . Time of first analgesic requirement will be noted in both groups and will be compared for statistical difference . Also total analgesic required to keep VAS <4 in 24 hrs will be noted in both the groups and calculatedted to see statistical difference in both the groups. Also any adverse effect of block will be noted. |