| CTRI Number |
CTRI/2017/04/008332 [Registered on: 11/04/2017] Trial Registered Prospectively |
| Last Modified On: |
05/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see which mode of administration of Injection nalbuphine is more effective in preventing itching caused by painkiller morphine |
|
Scientific Title of Study
|
Randomised double blind trial comparing efficacy of intravenous nalbuphine vs intrathecal nalbuphine for prevention of intrathecal morphine induced pruritus in orthopedic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai
Department of anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
04427440138 |
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai
Department of anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
04427440138 |
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai
Department of anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
04427440138 |
| Email |
pranjalikurhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute, Tiruporur Guduvanchery main road, Ammapettai, Kancheepuram District, Tamilnadu -603108 |
|
|
Primary Sponsor
|
| Name |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Tiruporur Guduvanchery main road, Ammapettai, kancheepuram District. Tamilnadu - 603108 |
| 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 Pranjali Kurhekar |
Shri Sathya Sai Medical College and esearch Institute, Ammapettai |
II floor operation theater complex, department of Anaesthesiology
Kancheepuram
TAMIL NADU |
9486414942
pranjalikurhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Undergoing orthopedic surgeries under spinal anaesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I - Intrathecal nalbuphine |
Patients in one group will receive 100 mcg of morphine and 400 mcg of nalbuphine intathecally along with 15 mg bupivacaine (heavy) |
| Comparator Agent |
Group II - Intravenous nalbuphine |
Patients will receive 100 mcg of morphine intrathecally along with 15 mg of bupivacaine (heavy) Then patients will be given 4 mg of nalbuphine, intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Willingness to participate in the study
2.ASA 1 or 2 physical status
3.Orthopaedic procedures under subarachnoid block
|
|
| ExclusionCriteria |
| Details |
1.ASA 3 and above
2.Psychiatric illness
3.Patients on anticoagulants
4Impaired renal or hepatic function
5.Major cardiac disease
6.Allergic to local anesthetic
7.Pre-existing dermatological conditions causing pruritus at the time of surgery
8.Already on opioid or poor resp reserve
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of pruritus between interventional and comparator group |
every 4 hourly for 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare severity of pruritus,
analgesia, incidence of nausea vomiting and respiratory depression, intraoperative hemodynamic stability, sensory level
|
Intraoperative vital every 15 minutes.
Sensory level every 5 minutes for intial 40 minutes
pruritus severity, nausea vomiting, respiratory depression every 4 hours for 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/05/2017 |
| 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 Applicable |
| 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)?
|
|
Brief Summary
|
Intrathecal morphine gives intense postoperative pain relief but is known to cause adverse effects like pruritus and respiratory depression. respiratory depression is uncommon at low doses but incidence of pruritus is 30-100%. Exact mechanism of intrathecal morphine induced pruritus is not known and many therapies are tried with limited success. Spinal kappa receptors can supress itch and hence drugs acting on them like nalbuphine can be effective.Previous studies have proved efficacy of intavenous nalbuphine over other agents in treating opioid induced pruritus without affecting analgesia and sedation. However studies proving efficacy of intrathecal nalbuphine for morphine induced pruritus are not available. |