| CTRI Number |
CTRI/2024/11/076170 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the pain relief of two techniques (regional anaesthetic) after surgery (decompression) on lower vertebral column (lumber). |
|
Scientific Title of Study
|
Comparison of Retrolaminar block and Erector spinae plane block for post-operative analgesia in patients undergoing lumbar spine decompression surgery A prospective 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 |
Sadik Mohammed |
| Designation |
Additional Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
| Phone |
9414849733 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sadik Mohammed |
| Designation |
Additional Professor |
| Affiliation |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
| Phone |
9414849733 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anju Raja |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.
Jodhpur RAJASTHAN 342005 India |
| Phone |
8003579818 |
| Fax |
|
| Email |
dranjuraja.22@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan. (India) 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan. (India) 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sadik Mohammed |
AIIMS JODHPUR |
Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur. Jodhpur RAJASTHAN |
09414849733
drmsadik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Jodhpur |
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 |
Erector spinae plane block |
All patients will receive ultrasound guided B/L Erector spinae plane block with 15 ml 0.375% Ropivacaine on either side and will be followed for analgesia using Numeric rating score for first 24 hours in the postoperative period. |
| Intervention |
Retrolaminar Block |
All Patients will receive ultrasound guided B/L Retrolaminar block with 15 ml 0.375% Ropivacaine on either side and will be followed for analgesia using Numeric rating score for first 24 hours in the postoperative period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients of either sex, aged between 18 to 65 years, belonging to ASA physical status 1 or 2, and scheduled for elective lumbar spine decompression surgery. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating female.
2. History of bleeding diathesis or receiving anticoagulant treatment.
3. Skin infection at the site of the block area.
4. Patients with baseline cognitive deficits sufficient to make objective pain assessment unreliable.
5. Opioid-dependent or chronic analgesic abuse.
6. Patients with known allergy to amide local anaesthetic or opioid. |
|
|
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 |
| The primary outcome of our study will be to compare postoperative pain score using Numeric Rating Scale (NRS) in GROUP RLB & GROUP ESPB. |
During the first 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the time to first rescue analgesic requirement.
2. To compare total analgesic consumed during the first 24 hrs after surgery.
3. To compare the intraoperative analgesic consumption.
4. To assess patient satisfaction score using Likert’s scale of both techniques.
5. To compare the side effects of both techniques.
|
During the first 24 Hours in the Postoperative period |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmsadik@gmail.com].
- For how long will this data be available start date provided 01-10-2027 and end date provided 30-09-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Surgical procedures on the spine often result in significant postoperative pain, with inadequate pain control affecting recovery and increasing chronic pain risk. Traditionally, opioids have been used for pain management, but ERAS protocols encourage a multimodal approach to reduce opioid reliance. Regional anesthesia techniques, particularly peripheral nerve blocks like the erector spinae plane (ESP) block and retrolaminar (RL) block, are gaining attention for their effectiveness and fewer side effects compared to neuraxial methods. The ESP block targets spinal nerve rami and sympathetic nerves, while the RL block focuses on dorsal rami. Both techniques have shown promise in reducing pain and opioid consumption, but more comparative studies are needed to determine the best option for postoperative analgesia in spine surgery. In the present study, patients will be randomly assigned to receive either a Retrolaminar block (RL) or an Erector Spinae Plane block (ES). Patients will undergo routine evaluations and fasting protocols. In the operating room, ASA standard monitors will be attached, induction of anesthesia will be performed, and the allocated block will be performed using ultrasound guidance after placing the patients in the surgical position (prone). Group ‘RLB’ (Retrolaminar Block )- All patients will receive ultrasound (US) guided Retrolaminar block with 15 mL of 0.375% Ropivacaine on either side. Group ‘ESPB’(Erector Spinae Plane Block)-All patients will receive ultrasound guided Erector Spinae Plane Block with 15 ml of 0.375% Ropivacaine on either side. Block performance time, number of attempts, and complications will be recorded. Anesthesia maintenance will include isoflurane and rocuronium, with intraoperative analgesia provided by fentanyl and paracetamol. Postoperative pain will be assessed using a numerical rating scale (NRS), and rescue analgesia will be administered as needed. Side effects and patient satisfaction will also be documented throughout the study period. |