| CTRI Number |
CTRI/2023/04/052091 [Registered on: 28/04/2023] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparision of morphine in two different doses as adjuvant to hyperbaric ropivacaine versus plain hyperbaric ropivacaine in lower limb surgeries. |
|
Scientific Title of Study
|
Comparision of intrathecal morphine in two different doses as an adjuvant to hyperbaric ropivacaine versus plain hyperbaric ropivacaine in lower limb orthopedic surgeries double blind randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Meena |
| Designation |
DNB Resident |
| Affiliation |
Bhagat Phool Singh Govt Mediacl College Sonepat Haryana |
| Address |
Deptt of Anaesthesiology, Bhagat phool singh govt medical college Sonepat Haryana 131305
Deptt of Anaesthesiology, Bhagat phool singh govt medical college Sonepat Haryana 131305
Sonipat
HARYANA
131305
India |
| Phone |
9897596682 |
| Fax |
|
| Email |
meenashivani118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh |
| Designation |
Professor |
| Affiliation |
Bhagat Phool Singh Govt Medical College Khanpur Kalan Sonepat Haryana |
| Address |
Department of Anaesthesia
Bhagat Phool Singh Govt Medical college
Khanpur kalan Sonepat
Department of Anaesthesia
Bhagat Phool Singh Govt Medical college
Khanpur kalan Sonepat
Sonipat
HARYANA
131305
India |
| Phone |
9728800122 |
| Fax |
|
| Email |
sarv.mlb007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Meena |
| Designation |
DNB Resident |
| Affiliation |
Bhagat Phool Singh Govt Mediacl College Sonepat Haryana |
| Address |
Deptt of Anaesthesia Bhagat phool singh govt medical college Sonepat Haryana 131305
Deptt of Anaesthesia Bhagat phool singh govt medical college Sonepat Haryana 131305
Sonipat
HARYANA
131305
India |
| Phone |
9897596682 |
| Fax |
|
| Email |
meenashivani118@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh govt medical college Sonepat |
|
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Primary Sponsor
|
| Name |
Bhagat phool singh govt medical college |
| Address |
Bhagat phool singh govt medical college Sonepat Haryana 131305 |
| Type of Sponsor |
Government medical college |
|
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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 Shivani Meena |
Bhagat phool singh govt medical college |
Department of Anaesthesia, OT, post operative room and orthopedic ward
Sonipat
HARYANA |
9897596682
meenashivani118@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group R |
The patient will be administered 3 ml (22.5 mg) of hyperbaric ropivacaine (0.75%) intrathecally.
|
| Intervention |
Group RM1 |
The patient will be administered 3 ml (22.5 mg) of hyperbaric ropivacaine (0.75%) with 100µgm morphine intrathecally.
|
| Comparator Agent |
Group RM2 |
The patient will be administered 3 ml (22.5 mg) of hyperbaric ropivacaine (0.75%) with 200µgm morphine intrathecally.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologists (ASA) grade I/II patients undergoing lower limb orthopedic surgical procedures under spinal anaesthesia.
Age group:18 - 65 years of any sex.
Patient voluntary participate in the study.
|
|
| ExclusionCriteria |
| Details |
Contraindication to spinal anaesthesia.
History of allergy to morphine or ropivacaine.
Patients with severe psychiatric disorder such as depression, dementia or drugs which could interfere with the comprehension of the study.
Patients with history of any cardiac disease, coagulopathy or any respiratory disorder.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be to evaluate the need for first analgesic dose. |
Post operatively after 2 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the secondary outcome will be to assess the onset and duration of sensory and motor blockade along with hemodynamic parameters and side effects |
Immediately after spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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 3 |
|
Date of First Enrollment (India)
|
10/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post operative pain after major orthopedic surgeries can be controlled by intrathecal administration of opioids and local anaesthetics. Effective intrathecal analgesia achieved through synergism between local anaesthetics and opioids is a well established phenomenon1.
In some of the studies, it is stated that addition of opioids like morphine or fentanyl to local anaesthetic like bupivacaine or ropivacaine may improve the quality of analgesia. As ropivacaine poses the natural vasopressor property, it might contribute to prolongation of analgesia by reducing its local clearance4. This is a double blind randomized controlled study in which 114 patients of ASA I and II patient, of either sex, aged between 18-65 years, with lower limb surgeries requiring sub-arachanoid block will be randomized into three groups of 38 each. Group R will receive hyperbaric 0.75% ropivacaine, Group RM1will receive hyperbaric 0.75% ropivacaine with 100 mcgm morphine and Group RM2 will receive hyperbaric 0.75% ropivacaine with 200 mcgm morphine. The primary objective is to determine the analgesia duration and secondary objective is to determine the efficacy of respective drugs in terms of onset and duration of sensory and motor blockade along with two dermatomal segment regression,and any side effect in each group |