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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [geetamanojkamal@gmail.com].

  6. 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.

  7. 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. 
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