| CTRI Number |
CTRI/2017/08/009445 [Registered on: 22/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of pain relief effect of 2 drugs when given with numbing medicine around the nerves coming out of the spinal cord for children undergoing surgeries below belly button |
|
Scientific Title of Study
|
Comparison of Analgesic Effects of Nalbuphine and Buprenorphine on Caudal Ropivacaine in Children Undergoing Infraumbalical surgery: - A Prospective Randomised Double Blinded 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 Sadasivan S Iyer |
| Designation |
Assistant Professor |
| Affiliation |
M.S. Ramaiah Medical College and Hospitals |
| Address |
Department of Anesthesiology and Pain
M.S. Ramaiah Medical College and Hopsitals
M.S.R. Nagar,
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
sadashivaniyer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadasivan S Iyer |
| Designation |
Assistant Professor |
| Affiliation |
M.S. Ramaiah Medical College and Hospitals |
| Address |
Department of Anesthesiology and Pain
M.S. Ramaiah Medical College and Hopsitals
M.S.R. Nagar,
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
sadashivaniyer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadasivan S Iyer |
| Designation |
Assistant Professor |
| Affiliation |
M.S. Ramaiah Medical College and Hospitals |
| Address |
Department of Anesthesiology and Pain
M.S. Ramaiah Medical College and Hopsitals
M.S.R. Nagar,
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
sadashivaniyer@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.S. Ramaiah Medical College and Hospitals;
M.S.R. Nagar, MSRIT POST,
Bengaluru 560054
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College and Hopsitals |
| Address |
M.S.R. Nagar, MSRIT Post,
Bangalore 560054
Karnataka, India |
| 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 Sadasivan S Iyer |
M.S.Ramaiah Medical College and Hospitals |
Department of Anesthesiology and Pain Medicine
2nd Floor, Operation theatre complex
OT no 5
M.S.R. Nagar, MSRIT Post,
Bengaluru 560054
Bangalore
KARNATAKA |
8971026127
sadashivaniyer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.S. Ramaiah Medical College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Any child between 1 -10 years presenting for infra umbalical surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
caudal ropivacaine |
After giving general anesthesia, children randomized to group R will receive Caudal epidural using 22g cannula under strict aseptic precautions and Injection ropivacaine(0.2%)(1ml/kg) and followed up post operatively for pain relief and side effects for 24 hours and time taken for first rescue analgesia will be considered |
| Intervention |
caudal ropivacaine with buprenorphine |
After giving general anesthesia, children randomized to group B will receive Caudal epidural using 22g cannula under strict aseptic precautions and Injection ropivacaine(0.2%)(1ml/kg) with 3 microgram/kg buprenorphine and followed up post operatively for pain relief and side effects for 24 hours and time taken for first rescue analgesia will be considered |
| Intervention |
caudal ropivacaine with nalbuphine |
After giving general anesthesia, children randomized to group N will receive Caudal epidural using 22g cannula under strict aseptic precautions and Injection ropivacaine(0.2%)(1ml/kg) with 0.1mg/kg nalbuphine and followed up post operatively for pain relief and side effects for 24 hours and time taken for first rescue analgesia will be considered |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
weight between 3- 20 kilograms
American Society of Anesthesiologists physical status 1 and 2
undergoing infraumbalical surgeries under general anesthesia supplemented with caudal epidural analgesia |
|
| ExclusionCriteria |
| Details |
1)patients having neurological, neuromuscular and coagulation disorders
2) patients having infection or deformity at site of caudal epidural injection
3) patients with known allergy to the study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesia |
Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation score
|
Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery |
| Degree of motor blockade |
Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery |
| Incidence of side effects |
Monitoring done at 30 minutes, 1, 1.5 ,2,8,14,20 and 24 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2016 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
http://dx.doi.org/10.1016/j.egja.2015.10.003
http://dx.doi.org/10.1016/j.egja.2015.11.005 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
CAudal epidural analgesia is a very common method of providing analgesia for children undergoing surgeries. It can be used for providing both intraoperative and post operative analgesia. A lot of adjuvant drugs are available for proving extended duration of post operative analgesia when mixed along with local anesthetic for caudal epidural. Ropivacaine is a long acting local anesthetic which in a concentration of 0.2% provides sensory block without motor blockade. Buprenorphine and Nalbuphine are synthetically derived opioids which provide analgesia without risk of respiratory depression due to its agonist-antagonist properties. the primary purpose of our study is to find out which among the two (nalbuphine and buprenorphine) is a better adjuvant when compared to each other and with plain ropivacaine in terms of duration of post operative analgesia, sedation, and incidence of side effects.
Primary hypothesis : -Nalbuphine is a better adjuvant than buprenorphine when given through epidural route with 0.2% ropivacaine in children undergoing infra umbilical surgeries Alternative Hypothesis : - Buprenorphine is a better adjuvant than nalbuphine when given through caudal epidural route with 0.2% ropivacaine in children undergoing infra umbilical surgeries |