| CTRI Number |
CTRI/2024/07/071636 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of dexmetomidine as an adjuvant to 0.2% ropivacaine in erector spinae plane block for operative pain relieve in participants undergoing total abdominal hysterectomies |
|
Scientific Title of Study
|
To study the effect of Dexmetomidine as adjuvant to 0.2 % Ropivacaine in Erector Spinae Plane block for post operative analgesia in total abdominal hysterectomies. |
| 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 Udeyana Singh |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital , Civil Lines , Tagore Nagar , Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8968580004 |
| Fax |
|
| Email |
udeyana@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachita |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital , Civil Lines , Tagore Nagar , Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
7973722987 |
| Fax |
|
| Email |
shivbro2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachita |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital , Civil Lines , Tagore Nagar , Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
7973722987 |
| Fax |
|
| Email |
shivbro2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical college and hospital, civil lines , tagore nagar , Ludhiana pin 141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Civil Lines, Tagore Nagar, Ludhiana, Punjab, India, 141001 |
| 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 |
| DR UDEYANA |
Dayanand Medical College And Hospital |
Department of anaesthsia, first floor
Ludhiana
PUNJAB |
8968580004
udeyana@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayanand medical college and hospital , ludhiana , India pin 141001 |
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 |
| Intervention |
Patient receiving block with dexmedetomidine |
Patients will receive ultrasound guided bilateral ESP block at T10 vertebrae level . Drug solution will contain 40 ml of 0.2 % ropivacaine and 0.5 mcg/kg dexmedetomidine . 20 ml of this solution will be deposited on either side. |
| Comparator Agent |
Patient receiving plane ropivacaine |
Patients will receive Ultrasound guided bilateral erector spinae plane block at T10 vertebra level after induction of general anaesthesia .Drug solution will contain 40 ml of 0.2 % ropivacaine and 1 ml of normal saline .20 ml of this solution will be admistered on each side . |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.American Society of Anaesthesiologists (ASA) I-III
2.Adults (30 to 70 years of age)
3.Female sex
4. Total abdominal hysterectomy patients with infra umblical incision |
|
| ExclusionCriteria |
| Details |
1.Refusal for inclusion in study
2.Local anaesthetic allergy / or previous anaphylactic shock from the same
3.Infection at block site
4.Patients with history of opioid abuse
5. Patients who are unable to comprehend VAS score |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time at which patient requests for first rescue analgesic in post-operative period. |
The time at which patient requests for first rescue analgesic in post-operative period in first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total opioid consumption in 24 hours
Bidirectional Visual Analogue Scale (VAS) score will be recorded at rest and on movement at designated intervals.
3)QoR -15 (Quality of Recovery) questionnaire will be accessed in post-operative period during the time of discharge from PACU .
|
24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="0"
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 abdominal hysterectomies are associated with significant post-operative pain. Untreated or partially treated pain leads to peri operative stress response , adverse cardiac events , poor wound healing and delayed recovery after surgery. To minimize perioperative opioid use , regional anaesthesia techniques are being used to provide high quality analgesia. The interfascial plane block known as the erector spinae plane block (ESPB) involves deposition of local anesthetic deep to the erector spinae muscle anterior to transverse process of vertebrae .Dexmedetomidine is an alpha 2 agonist which has sedation and analgesic properties .The mechanism of action of dexmedetomidine is via α-2A, α-2B and α-2C adrenoceptors that have shown to cause vasoconstriction which helps in prolongation of effect of local anaesthetics. It has anxiolytic , hemodynamic and cardiorespiratory stabilizing properties |