| CTRI Number |
CTRI/2023/04/052072 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of postoperative analgeisa using transdermal buprenorphine vs. fentanyl in patients undergoing lower limb orthopaedic surgeries and lower abdominal surgeiries |
|
Scientific Title of Study
|
a comparative study of transdermal buprenorphine vs. fentanyl for postoperative analgesia in patients undergoing infraumblical and lower limb orthopaedic 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 Harjinder Kaur |
| Designation |
Assistant professor |
| Affiliation |
government medical college, amritsar |
| Address |
Government medical college, circular road, amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9855895452 |
| Fax |
|
| Email |
harjinderkaur5453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harjinder Kaur |
| Designation |
Assistant professor |
| Affiliation |
government medical college, amritsar |
| Address |
Government medical college, circular road, amritsar
PUNJAB
143001
India |
| Phone |
9855895452 |
| Fax |
|
| Email |
harjinderkaur5453@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harjinder Kaur |
| Designation |
Assistant professor |
| Affiliation |
government medical college, amritsar |
| Address |
Government medical college, circular road, amritsar
PUNJAB
143001
India |
| Phone |
9855895452 |
| Fax |
|
| Email |
harjinderkaur5453@gmail.com |
|
|
Source of Monetary or Material Support
|
| material support in form of medications required for the study |
|
|
Primary Sponsor
|
| Name |
Dr Harjinder Kaur |
| Address |
Department of Anaesthesia, Government medical college, Amritsar |
| Type of Sponsor |
Government 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 Harjinder Kaur |
Guru Nanak Dev Hospital |
1st floor, post operaive recovery room, guru nank dev hospital, majitha road, amritsar 143001
Amritsar
PUNJAB |
9855895452
harjinderkaur5453@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison of transdermal buprenorphine and fentanyl for postoperative analgesia in patients undergoing infraumblical and lower limb orthopedic surgeries |
TECHNIQUE
Pre-operatively:
Patches will be applied on the hairless areas of upper arm, 12–16 hours before surgery. After application, patches will be pressed firmly for 30 seconds, and the patient will be monitored for any skin irritation and episodes of respiratory depression and hypoxia by pulse oximetry overnight.
A baseline recording of the vital parameters- heart rate (HR), non-invasive blood pressure (NIBP), respiratory rate (RR) and oxygen saturation (SpO2) will be done.
|
| Comparator Agent |
transdermal buprenorphine |
Patches will be applied on the hairless areas of upper arm, 12–16 hours before surgery. After application, patches will be pressed firmly for 30 seconds, and the patient will be monitored for any skin irritation and episodes of respiratory depression and hypoxia by pulse oximetry overnight. |
| Comparator Agent |
transdermal fentanyl |
Patches will be applied on the hairless areas of upper arm, 12–16 hours before surgery. After application, patches will be pressed firmly for 30 seconds, and the patient will be monitored for any skin irritation and episodes of respiratory depression and hypoxia by pulse oximetry overnight. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Men and women between 18-60 years, who have given their consent
2. ASA classes I and II
3.Posted for infraumbilical surgeries like inguinal hernia repair, haemorroidectomy, hydrocele surgery, surgery for varicose veins and lower limb orthopaedic surgeries
|
|
| ExclusionCriteria |
| Details |
1. History of allergy to opioids
2. History of/ongoing drug abuse
3. Patients who are already using a transdermal opioid patch
4. Pregnant patients
5. Patients taking opioids, NSAIDS, or any pain medication for more than 3 months
6. Patients on antiepileptics or antidepressants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of the study drugs in terms of duration of analgesia in infraumbilical and lower limb orthopaedic surgeries up to 48 hours.
2. Total rescue analgesia received in 48 hours.
|
1. To compare the efficacy of the study drugs in terms of duration of analgesia will be measured every 2 hourly upto 12 hours and then 4 hourly upto 48 hours
2. Total rescue analgesia received in 48 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic variability
2. Side effects like pruritus, respiratory depression (SpO2 less than 90% or
respiratory rate 8), sedation (as per Ramsay Sedation Scale score of 5 or 6), and postoperative nausea and vomiting. Outcomes will be noted and analyzed at different timelines for 48 hours.
|
48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/04/2023 |
| 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="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transdermal
opioids are newer modality in use for the control of postoperative pain because
of their noninvasiveness, longer duration of action, sustained blood levels and
minimal side effects. The aim of this study
is to evaluate the efficacy of buprenorphine transdermal patch 10 μg·h‑1 and fentanyl
transdermal patch 25 μg·h‑1
for relief of pain in the postoperative
period in patients undergoing infraumbilical and lower limb orthopaedic surgeries.
Our study will be a prospective, interventional, randomized,
single blinded clinical study in 60 patients posted for infraumbilical and lower limb orthopaedic surgeries based on
the inclusion and exclusion criteria mentioned below. Patients will be randomly allocated into the two groups ‘B’
and ‘F’ using sealed envelope technique. Mean Numeric rating scale score, total rescue
analgesic requirement, drug-related adverse effects, and haemodynamic status will be evaluated till
48 hours in the postoperative period. The data will then be compiled, tabulated
and statistically analyzed with the latest software. |