| CTRI Number |
CTRI/2023/07/055003 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post operative pain relief in lumber spine surgery patients |
|
Scientific Title of Study
|
Comparison of the post operative analgesia after epidural application of gel foam soaked in morphine ropivacaine and morphine ropivacaine combination in patients undergoing single level lumbar laminectomy a randomised 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 Geeta Singariya |
| Designation |
Senior Professor |
| Affiliation |
Dr. S.N. medical collage, Jodhpur |
| Address |
Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur
RAJASTHAN
342001 Dr. S.N. medical collage, Jodhpur Jodhpur RAJASTHAN 342001 India |
| Phone |
09414803554 |
| Fax |
|
| Email |
geetamanojkamal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lovie Singla |
| Designation |
Junior Resident |
| Affiliation |
Dr S N medical collage, Jodhpur |
| Address |
Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur
RAJASTHAN
342001 MDM hospital Dr S N Medical Collage Jodhpur Jodhpur RAJASTHAN 342001 India |
| Phone |
8360114502 |
| Fax |
|
| Email |
drlovieanaesthesia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Geeta Singariya |
| Designation |
Senior Professor |
| Affiliation |
Dr S N medical collage, Jodhpur |
| Address |
Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur
RAJASTHAN
342001 Dr S N medical collage, Jodhpur Jodhpur RAJASTHAN 342001 India |
| Phone |
09414803554 |
| Fax |
|
| Email |
geetamanojkamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur
RAJASTHAN
342001 |
|
|
Primary Sponsor
|
| Name |
M D M Hospital Dr S N Medical College Jodhpur |
| Address |
Shastri nagar Jodhpur Rajasthan |
| 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 Geeta Singariya |
MDM hospital, Dr S N Medical collage, Jodhpur |
OT Complex First floor Department of Anaesthesia M D M Hospital Dr S N Medical College Shastri Nagar Dr S N medical collage, Jodhpur
Jodhpur
RAJASTHAN Jodhpur RAJASTHAN |
9414803554
geetamanojkamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr S N Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Morphine |
Gelfoam soaked in inj morphine 5 mg (0.5 ml) + 10 ml of 0.9% sodium chloride in epidural space |
| Comparator Agent |
Morphine Ropivacaine |
Gelfoam soaked in inj morphine 5 mg (0.5 ml) + 10 mL of 0.5% ropivacaine in epidural space |
| Intervention |
Ropivacaine |
Gelfoam soaked in 10 mL of 0.5% ropivacaine + 0.5 ml of 0.9% sodium chloride in epidural space |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I /II scheduled to undergo single-level lumbar laminectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1 Body mass index ≥ 25 kg/m2
2 Moderate to severe heart or lung disease
3 History of previous lumbar spinal surgery
4 Prior neurological disease
5 Prior neuromuscular disease or psychological
disease
6 History of preoperative opioid use or any
history of substance abuse or on steroids
7 History of allergic reactions to local
anesthetics.
8 Patients with excessive bleeding, cerebrospinal
fluid leak, or requiring placement of a drain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of postoperative analgesia in term of VAS score after epidural application of gel foam soaked in morphine ropivacaine morphine ropivacaine combination in patients undergoing single level lumbar laminectomy |
24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Duration of analgesia
2 Total 24 hour rescue analgesic consumption
3 RAMSAY SEDATION SCORE
4 Patient satisfaction
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
15/07/2023 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geetamanojkamal@gmail.com].
- For how long will this data be available start date provided 27-08-2023 and end date provided 27-06-2028?
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
|
All patients will undergo preoperative anaesthetic evaluation and will be explained about the visual analog scale (VAS) (0-10, where 0 =no pain and 10=worst imaginable pain). All patients will be kept fasting overnight and will be pre-medicated with tablet lorazepam 0.05 mg/kg and tablet ranitidine 150 mg orally the night before surgery. On the day of surgery, in the preoperative area, an intravenous line will be secured and normal saline infusion will be started. All patients will be premedicated with midazolam 2mg, metoclopramide 10 mg, and glycopyrrolate 0.2 mg intravenously half an hour before induction in the preoperative area. Patients will undergo single-level lumbar canal decompression, in the standard prone position on a Wilson frame, via a midline incision, under general anesthesia. After shifting to the operation theatre, standard monitoring i.e. electrocardiogram (ECG), pulse oximetry (Spo2), noninvasive blood pressure (NIBP), end-tidal carbon dioxide (EtCO2), and body temperature will be started and baseline vital parameters will be recorded and monitoring will be continued till extubation. General anaesthesia will be induced with fentanyl 2 µg/kg, propofol 2-3 mg/kg till loss of verbal response and tracheal intubation will be facilitated by atracurium 0.5mg/kg, intravenously. Subsequently, anaesthesia will be maintained using isoflurane achieving an end-tidal concentration of 0.9 to 1.2% in a mixture of 60% N2O in O2. Neuromuscular relaxation will be maintained with intermittent atracurium bolus (0.15 mg/kg every 20 minutes). Ventilation will be adjusted to maintain EtCO2 between 30 and 35 mm Hg. Intraoperative rescue analgesia will be provided by intravenous fentanyl 0.5-1 μg/kg boluses as judged by an increase in heart rate or systolic blood pressure by more than 20% of the baseline. Patients will be divided into three groups by using computer-generated random table numbers. At the end of the surgical procedure, after securing hemostasis and before final closure, in group M, a piece of absorbable gel foam soaked in inj morphine 5 mg (0.5 ml) + 10 ml of 0.9% sodium chloride will be placed in epidural space over the paraspinal region, above the nerve roots by the surgeon. In group R gel foam was soaked in 10 mL of 0.5% ropivacaine + 0.5 ml of 0.9% sodium chloride in epidural space and in group MR: Gelfoam soaked in inj morphine 5 mg (0.5 ml) + 10 mL of 0.5% ropivacaine in epidural space. After placing the gel foam, the drug solution will be allowed to remain in the wound for a contact time of 60 seconds. Thereafter, the wound will be closed in layers without mopping or suctioning. All patients will be given inj ondansetron 0.1mg/kg prophylactically 30 minutes before reversal. At the end of surgery, patients will be turned supine and residual neuromuscular blockade will be reversed with i.v. neostigmine 50 µg.kg-1 and glycopyrrolate 10 µg.kg-1 and the trachea will be extubated when the patient is fully awake and breathing adequately and will be shifted to post anaesthesia care unit (PACU). In the postoperative period pain ratings, at rest and on movement, will be measured by a 0–10 visual analog scale (VAS) at intervals of 0, 1, 2, 4, 8, 12,18, and 24 hrs by an anaesthetist blinded to the drugs administered. Pulse, blood pressure (BP), and respiratory rate will also be noted during this time period. Tramadol 100 mg i/v slowly will be given as a rescue analgesic in case the patient’s VAS score is ≥ 4. Total 24-hour tramadol consumption and time to first request for rescue analgesic will be recorded. If VAS score ≥ 4 even after inj tramadol, inj paracetamaol 100 ml (1 gram) will be given as rescue analgesia. Side effects like nausea, vomiting, urinary retention, sedation, and adverse effects with the use of study drugs in all three groups will also be noted. |