| CTRI Number |
CTRI/2025/03/081806 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different doses of Morphine with Levobupivacaine administered in spinal anaesthesia for pain relief after surgery in patients undergoing knee replacement.
|
|
Scientific Title of Study
|
Comparison of two different doses of intrathecal Morphine as an adjuvant to 0.5% heavy Levobupivacaine for postoperative analgesia in patients undergoing Total knee replacement. |
| 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 Shubhangi Agrawal |
| Designation |
PG Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesia OT Complex 2nd Floor Mahatma Gandhi Hospital Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9890777542 |
| Fax |
|
| Email |
coolshubh1995@gmail.coml |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sapna Singh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesia OT Complex 2nd Floor Mahatma Gandhi Hospital Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829141123 |
| Fax |
|
| Email |
sapnamp93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sapna Singh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Anaesthesia OT Complex 2nd Floor Mahatma Gandhi Hospital Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829141123 |
| Fax |
|
| Email |
sapnamp93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Jaipur, Rajasthan, India(302022) |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospitaljaipur |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, Rajasthan India (302022) |
| Type of Sponsor |
Private 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 Shubhangi Agrawal |
Mahatma Gandhi Medical College and Hospital |
Department of Anaesthesia and Critical Care, Mahatma Gandhi Hospital, Sitapura, Jaipur
Jaipur
RAJASTHAN |
9890777542
coolshubh1995@gmail.coml |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MGMC, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
morphine + 0.5% heavy Levobupivacaine |
Intrathecal morphine 100 mcg + Intrathecal 0.5% heavy Levobupivacaine 15 mg
To be given to 35 patients undergoing TKR
|
| Intervention |
morphine + 0.5% heavy Levobupivacaine |
Intrathecal morphine 200 mcg + Intrathecal 0.5% heavy Levobupivacaine 15 mg To be given to 35 patients undergoing TKR |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 18 to 75 yrs
2. All genders
3. ASA Physical status I – III
4. All patients placed for Elective Total Knee Replacement under Spinal Anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled co-morbidities like hypertension, Diabetes, Heart Disease
2. Opioid addicts
3. Patients already on opioids.
4. All contraindications for spinal anaesthesia.
5. Pregnant and Lactating females.
6. Mentally retarded.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the duration of post operative analgesia amongst two groups using Visual Analogue Scale(VAS) score.
2. To compare time to first rescue analgesic in both groups.
|
0, 2hr, 4hr, 8hr, 12hr, 16hr, 24hr |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of effect on Onset and Duration of Sensory and Motor Block in both group
2. Peri-operative hemodynamic monitoring- HR, BP, RR, SpO2 within 24 hrs
3. Comparison of occurrence of Adverse Reactions (nausea/vomiting, pruritis , urinary
retention, constipation, respiratory depression ) within 24 hrs after surgery in either group.
|
Peri-operative hemodynamic monitoring -
1. Intra-operatively : every 5 min
2. Post-operatively : 2hr, 4hr, 8hr, 12hr, 16hr, 24hr
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - NO
|
|
Brief Summary
|
After getting clearance from Institute Ethics Committee and written informed consent, patients planned for Total Knee Replacement, will be included in this study. Using a computer generated random number table, patients will be randomly allocated to 2 groups each comprising of 35 patients. After ensuring double blinding- Group A will receive SAB with morphine 100 mcg + Levobupivacaine(heavy) 15 mg, and Group B will receive SAB with morphine 200 mcg + Levobupivacaine(heavy) 15 mg. An epidural catheter will then be placed in all patients which will be activated at the time of demand for first rescue analgesic. After that postoperative pain will be assessed at 0, 2hr, 4hr, 8hr, 12hr, 16hr, 24hr using Visual Analogue Scale. When VAS>/= 4, rescue analgesic (Inj PCM 1gm i.v. + Epidural top up with 0.2% Ropivacaine 8ml + Tramadol 100mg) will be given. Onset and duration of both, sensory and motor block will be noted. Intra-operative hemodynamic monitoring will be done every 5 min and post-operatively at 2hr, 4hr, 8hr. 12hr, 16hr, 24hr. Adverse effects like Post-operative nausea and vomiting, pruritis, urinary retention, constipation and respiratory depressions will be noted upto 24 hrs postoperatively.
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