| CTRI Number |
CTRI/2024/07/070046 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Prolongation of pain relief after injection of two drugs, dexamethasone and dexmedetomidine mixed with local anaesthetic above lamina of spine : a comparative study in patients of spine surgeries. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of dexamethasone and dexmedetomidine as adjuvants to ropivacaine in ultrasound guided retrolaminar block for adult patients undergoing thoracolumbar spine surgery: a randomized controlled trial |
| 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 Aakanksha Hiremath |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Room no 13, OPD Ground Floor
Department of Anaesthesiology
AIIMS Patna
Bihar
Patna BIHAR 801507 India |
| Phone |
9811192382 |
| Fax |
|
| Email |
aakanksha.hiremath@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amarjeet Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Room No. 505, IPD 5th Floor
Department of Anaesthesiology
AIIMS Patna
Bihar
Patna BIHAR 801507 India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aakanksha Hiremath |
| Designation |
Academic Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Room no 13, OPD Ground Floor
Department of Anaesthesiology
AIIMS Patna
Bihar
Patna BIHAR 801507 India |
| Phone |
9811192382 |
| Fax |
|
| Email |
aakanksha.hiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology, 5th floor IPD AIIMS Patna
Bihar-801507
India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department Of Anaesthesiology IPD 5th Floor
AIIMS Patna,
Bihar-801507
India |
| Type of Sponsor |
Government 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 Aakanksha Hiremath |
AIIMS Patna |
Department of Anaesthesiology
5th Floor IPD building
AIIMS Patna Patna BIHAR |
9811192382
aakanksha.hiremath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
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 |
Retrolaminar block with 0.2% ropivacaine and adjuvant dexmedetomidine |
Retrolaminar block using 0.2% ropivacaine 20 ml and 1mcg/kg dexmedetomidine injected bilaterally at the level of target vertebrae situated in the middle of skin incision. (total volume will be 40 ml) |
| Intervention |
Retrolaminar block with 0.2% ropivacaine with adjuvant dexamethasone |
Retrolaminar block using plain 0.2% ropivacaine 20 ml and 4mg dexamethasone injected bilaterally at the level of target vertebrae situated in middle of skin incision. (total volume will be 40 ml) |
| Comparator Agent |
Retrolaminar block with 0.2% ropoivacaine alone |
Retrolaminar block using plain 0.2% ropivacaine 20 ml injected bilaterally at the level of target vertebrae situated in middle of skin incision. (total volume will be 40 ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II patients undergoing thoracolumbar spinal surgeries less than or equal to five segments.
|
|
| ExclusionCriteria |
| Details |
ASA III or more
Allergy to the drugs
Coagulopathy
Infection at puncture site
Mental disorder, Communication failure, unable to discriminate
cutaneous pin prick.
Chronic use of analgesics, inability to operate PCA pump
Preexisting spinal cord disease prior lumbar spine surgery
BMI more than or equal to 30 |
|
|
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 |
To compare the time to first rescue analgesic requirement in postoperative period.
|
Within 24 hours of postoperative period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total postoperative fentanyl consumption |
within 24 hours of postoperative period |
| To evaluate additional intraoperative fentanyl consumption in all groups. |
From administration of block till the end of surgery |
Severity of pain during postoperative period
measured through NRS scale |
1,2, 4, 6, 12, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="1" Months="6" 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
|
In the landscape of thoracolumbar spine surgeries, effective
perioperative pain management stands as a pivotal element in controlling post
operative pain and optimizing pain relief allowing for early ambulation and
decreased hospital stay. A wide of number of regional analgesia techniques have
been utilised to manage this pain like paravertebral blocks, epidural blocks
and interfascial blocks like erector spinae plane block.
Retrolaminar block (RLB) is a novel interfacial plane block which has
been used to provide perioperative analgesia in patient undergoing lumbar
surgeries, breast surgeries, nephrectomy, thoracotomy and in retroperitoneal
laproscopic surgeries. In all of these studies only local anaesthetic
(bupivacaine or ropivacaine) was used. These local anaesthetics have limited
duration of action typically, around 10 hours. Several drugs (opioids,
dexamethasone) have been used as adjuvants to local anaesthetics to prolong the
duration of analgesia in erector spinae plane block for spine surgeries.
However, the efficacy of these adjuvants has not been established in
retrolaminar plane blocks. Our study aims to determine the benefits of adding
dexmedetomidine or dexamethasone as adjuvant to ropivacaine in prolonging the
duration of postoperative analgesia, improve postoperative pain score and
patient satisfaction.
|