CTRI Number |
CTRI/2025/04/085365 [Registered on: 23/04/2025] Trial Registered Prospectively |
Last Modified On: |
22/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparing two interventions for pain control in post operative period in patients undergoing lumbar spine surgery |
Scientific Title of Study
|
Comparison of intrathecal morphine versus erector spinae plane block for postoperative pain control in patients for lumbar spine surgery:a double-blind prospective comparative study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Arfan Ahmed J S |
Designation |
Assistant professor |
Affiliation |
Velammal medical college hospital and research institute |
Address |
Department of anaesthesia,
Velammal medical college hospital and research institute,
Chinthamani,
Madurai Department of anaesthesia,
Velammal medical college hospital and research institute,
Chinthamani,
Madurai Madurai TAMIL NADU 625009 India |
Phone |
7795194452 |
Fax |
|
Email |
arfanahmed007@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Manikandan B |
Designation |
Head of department of anaesthesia |
Affiliation |
Velammal medical college hospital and research institute |
Address |
Department of anaesthesia,
Velammal medical college hospital and research institute,
Chinthamani,
Madurai. Department of anaesthesia,
Velammal medical college hospital and research institute,
Chinthamani,
Madurai. Madurai TAMIL NADU 625009 India |
Phone |
9443753737 |
Fax |
|
Email |
drmanib@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Arfan ahmed J S |
Designation |
Assistant professor |
Affiliation |
Velammal medical college hospital and research institute |
Address |
Department of anaesthesia,
Velammal medical college hospital and research institute,
Chinthamani,
Madurai Department of anaesthesia,
Velammal medical college hospital and research institute,
Chinthamani,
Madurai Madurai TAMIL NADU 625009 India |
Phone |
7795194452 |
Fax |
|
Email |
arfanahmed007@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Velammal medical college hospital and research institute |
Address |
Velammal medical college and hospital
Velammal Village,
Madurai - Tuticorin,
Airport-Mattuthavani Ring Rd, Chinthamani,
Madurai,
Tamil Nadu
Pin 625009 |
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 Arfan ahmed J S |
Velammal medical college hospital and research institute,Madurai |
GSOT Fifth floor,
Velammal medical college hospital and research institute,
Velammal Village,
Madurai-Tuticorin Ring Road,
Anuppanadi,
Madurai.
625009 Madurai TAMIL NADU |
7795194452
arfanahmed007@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,Velammal Medical College Hospital and Research Institute,Madurai. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Erector spinae plane block |
40ml of 0.25% of bupivacaine is given under ultrasound guidance before surgery. |
Intervention |
Intrathecal Morphine |
0.2 mg of morphine is given intrathecaly before surgery. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
ASA 1 & 2 patients scheduled to undergo elective lumbar spine surgery |
|
ExclusionCriteria |
Details |
1.Patient refusal.
2.Allergy to any of the study drugs.
3.Contraindications to regional technique e.g.,infection around site of block ,any coagulation disorder, sepsis.
4.History of analgesic dependence (long term use) and opiate tolerance.
5.Contraindications to intrathecal morphine e.g.,local infection in intrathecal administration site.
6.More than two level of vertebrae involving in surgery. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
1.VAS Score.
2.Postoperative analgesia use paracetamol/tramadol usage. |
1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours. after operation.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Time to first analgesic requirement after surgery.
2.Incidence of intervention related side effects in both the groups(Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention, local anesthetic systemic toxicity,local hematoma ).
3.Hemodynamic response to surgical stimulus during the procedure(HR,SPO2,NIBP at baseline ,post intubation,proning,30 min,1 hr into surgery). |
1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours after operation. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
10/05/2025 |
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="0" Months="3" 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
|
After spine surgery,
postoperative pain could be moderate to severe for more than half of
patients.Surgical trauma, neuropathy and inflammation are
factors contributing to this.Erector spinae plane block is
fascial plane block used widely for post operative analgesia of spine
surgeries.This involves injecting a local anesthetic into the plane between the
erector spinae muscle and the transverse process of the vertebra. The
local anesthetic spreads on a plane caudally and cranially, allowing the
sympathetic nerve fibers, as well as the spinal nerves’ dorsal and ventral rami
to be blocked.Direct injection of
morphine into the intrathecal space also allows to directly act on
opioid receptors within the brain and substantia gelatinosa of
the spinal cord resulting in a robust analgesia after spine surgeries.
The current study aimed
to assess and compare the efficacy and safety of intrathecal morphine
with erector spinae plane block in patients undergoing elective
lumbar spine surgeries.A total of 100 patients aged between 18 and 65 years of
either sex will be selected from the patients posted for elective lumbar spine surgery. Patients will be divided into two groups: Group A
patients will receive 0.2 mg intrathecal morphine at any one space between
L2-L5 level and Group B will receive bilateral erector spinae plane block at
Lumbar level L1-L5 by using 40 mL of 0.25 % bupivacaine before starting the surgery for postoperative analgesia. In the
perioperative period, pain will be assessed by hemodynamic parameters
(heart rate and mean arterial pressure,SpO2), visual analogue scale and patient satisfaction score. Time
to first rescue analgesic requirement and incidence of any adverse events will
also be noted. |