| CTRI Number |
CTRI/2025/09/095341 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing opioid-free anaesthesia with retrolaminar block versus conventional anaesthesia for faster recovery after lower back surgeries |
|
Scientific Title of Study
|
A randomised clinical trial to compare the efficacy of opioid free anaesthesia with retrolaminar block and conventional
anaesthesia method to know enhanced recovery in posterior
lumbosacral surgeries |
| 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 Arya Srinivasan |
| Designation |
Junior Resident |
| Affiliation |
Shri B. M. Patil medical college, hospital and research center |
| Address |
Department of Anaesthesiology,Shri B. M. Patil medical college, Vijayapura, Karnataka, India - 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9207277361 |
| Fax |
|
| Email |
aryasrinivasan98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivanand L Karigar |
| Designation |
Professor |
| Affiliation |
Shri B. M. Patil medical college, hospital and research center |
| Address |
Department of Anaesthesiology,Shri B. M. Patil medical college, Vijayapura, Karnataka, India - 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya Srinivasan |
| Designation |
Junior resident |
| Affiliation |
Shri B. M. Patil medical college, hospital and research center |
| Address |
Department of Anaesthesiology,Shri B. M. Patil medical college, Vijayapura, Karnataka, India - 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9207277361 |
| Fax |
|
| Email |
aryasrinivasan98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Arya Srinivasan |
| Address |
Shri B. M. Patil medical college and research Center, Solapur Road, Vijayapura, Karnataka, India - 586103 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arya Srinivasan |
Shri B. M. Patil medical college, hospital and research center |
Department of Anaesthesiology, Shri B. M. Patil medical college, hospital and research center, Vijayapura, Karnataka, India, 586103
Bijapur
KARNATAKA |
9207277361
aryasrinivasan98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE(Deemed to be university) institutional ethics committee |
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 |
conventional anaesthesia method |
General anaesthesia was induced using IV propofol 2 mg/kg and 0.5 µg/kg dexmedetomidine over 10 min, and endotracheal intubation was facilitated with IV atracurium (0.5 mg/kg). Anaesthesia was maintained using 1.5% isoflurane in a mixture of 50% oxygen(O2) and 50% air,1 µg/kg fentanyl and atracurium 0.1 mg/kg/h.Any intra-operative complications, including hypotension and bradycardia (20% from baseline), were recorded, and in such cases, 0.5 mg/kg ephedrine and 0.01 mg/kg atropine were administered. At the end of the surgery, the inhalational anaesthesia was stopped, and the residual neuromuscular blockade was antagonised using 0.05 mg/kg IV neostigmine and 0.01 mg/kg IV atropine. All patients were extubated, and the time from isoflurane discontinuation to extubation was recorded. The time from isoflurane discontinuation to the first response to a verbal command was also recorded, and then the patients were transferred to the PACU with standard monitors |
| Intervention |
Retrolaminar block |
General anaesthesia was induced using
IV propofol 2 mg/kg and 0.5 µg/kg dexmedetomidine
over 10 min, and endotracheal intubation was
facilitated with IV atracurium (0.5 mg/kg). Anaesthesia was maintained using
1.5% isoflurane in a mixture of 50% oxygen(O2) and
50% air and atracurium 0.1 mg/kg/h. In the prone position, after making a surgical wound
incision and reaching the selected spinous process, an
18-G needle from a 20-mL syringe was inserted beside
the spinous process and advanced until the needle
tip made contact with the lamina. After ensuring no
negative aspiration, the anaesthesiologist prepared a
solution consisting of 15 mL of bupivacaine 0.25%,
2 mL (8 mg) of dexamethasone, and 2 mL (200 mg)
of magnesium sulphate 10%. The neurosurgeon
then injected the solution [Figure 1a]. The same
steps were repeated on the other side. The depth of anaesthesia was guided by the Sedline monitor. In addition, the Patient State Index (PSI) was kept between 25 and 50 to ensure optimal analgesia
and hypnosis. If the PSI value exceeded 50 ,the patient was treated with IV
fentanyl 0.5 µg/kg, and the treatment was recorded. Any
intra-operative complications, including hypotension
and bradycardia (20% from baseline), were recorded,
and in such cases, 0.5 mg/kg ephedrine and 0.01 mg/kg atropine were administered. At the end of the surgery,
the inhalational anaesthesia was stopped, and the
residual neuromuscular blockade was antagonised
using 0.05 mg/kg IV neostigmine and 0.01 mg/kg IV
atropine. All patients were extubated, and the time
from isoflurane discontinuation to extubation was recorded. The time from isoflurane discontinuation
to the first response to a verbal command was also
recorded, and then the patients were transferred to the PACU with standard monitors. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I or II, with BMI between 25 and 30kg/m2, undergoing elective lumbosacral spine surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with known allergies to medications used in this study, patients undergoing long term pain management, patients with preexisting respiratory, renal, hepatic or cardiovascular conditions, patients with clotting disorders or coagulopathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative pain intensity at rest and during movement and to assess time from isoflurane discontinuation to tracheal extubation and recovery time |
30 minutes, 2 hours, 4 hours, 8 hours,12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes of the trial are - to measure time for first request of rescue analgesic (ketorolac) after surgery, to calculate total ketorolac consumption within first 24 hours postoperatively, to assess time of discharge from PACU (Post anaesthesia care unit), to evaluate incidence of postoperative side effects particularly nausea, vomiting & sedation during firt 24 hours postoperatively & to evaluate & compare the levels of inflammatory marker(C Reactive protein-CRP) in pre & postoperative periods |
24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
24/10/2025 |
| 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="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
|
General physical examination and routine blood investigations will be conducted preoperatively. In the operating theatre standard monitors will be connected. Anaesthesia will be induced using Propofol and Dexmeditomidine fpr both groups. Endotracheal intubation will be facilitated using iv Atracurium. Maintenance of anaesthesia will be using Isoflurane with atracurium. Additional Fentanyl will be given to conventional anaesthesia group. Before skin incision, both groups receive Inj. Paracetamol. After skin incision, Retrolaminar block with opioid free anaesthesia group will be given Retrolaminar block with 0.25% Bupivacaine, Dexamethasone and MgSO4.At the conclusion of surgery, isoflurane will be discontinued and residual neuromuscular blockage reversed using iv neostigmine and glycopyrrolate. |