| CTRI Number |
CTRI/2018/05/013594 [Registered on: 01/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the analgesic effect of buprenorphine through epidural and trandermal routes in patients undergoing hysterectomy. |
|
Scientific Title of Study
|
POSTOPERATIVE ANALGESIA WITH EPIDURAL INFUSION OF BUPRENORPHINE VERSUS TRANSDERMAL BUPRENORPHINE IN TOTAL ABDOMINAL HYSTERECTOMY: A COMPARATIVE STUDY |
| Trial Acronym |
PAEVT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJU KRISHNAN |
| Designation |
JuniorResident |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College, Kozhikode.
Kozhikode 673008
Kerala
Government Medical College Kozhikode
Kozhikode
Kerala 673008
Kozhikode
KERALA
673008
India |
| Phone |
919747859448 |
| Fax |
|
| Email |
anjukvk12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Binu Sajid |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College, Kozhikode.
Kozhikode 673008
Kerala
Government Medical College Kozhikode
Kozhikode
Kerala 673008
Kozhikode
KERALA
673008
India |
| Phone |
919447324632 |
| Fax |
|
| Email |
binusajid@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Binu Sajid |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Kozhikode |
| Address |
Department of Anaesthesiology
Government Medical College, Kozhikode.
Kozhikode 673008
Kerala
Government Medical College Kozhikode
Kozhikode
Kerala 673008
Kozhikode
KERALA
673008
India |
| Phone |
919447324632 |
| Fax |
|
| Email |
binusajid@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Kozhikode, Kozhikode, Kerala.
Pin 673008 |
|
|
Primary Sponsor
|
| Name |
Anju Krishnan |
| Address |
Junior Resident
Government Medical College Kozhikode, Kerala 673008 |
| 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 |
| Anju Krishnan |
Government Medical College Kozhikode |
Government Medical College Kozhikode
pin 673008
Kozhikode
KERALA |
919747859448
anjukvk12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Undergoing Hysterectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural buprenorphine infusion |
Epidural buprenorphine infusion for postoperative analgesia after hysterectomy |
| Comparator Agent |
Standard Parenteral Analgesics |
Standard Parenteral Analgesics for postoperative analgesia |
| Intervention |
Transdermal buprenorphine patch |
Postoperative analgesia with Transdermal buprenorphine patch after hysterectomy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
a) Age between20 and 65 years.
American Society of Anaesthesiologists ASA I OR II.
Expected hospital stay after intervention atleast for 72 hrs.
Weight 45kg -65kg.
|
|
| ExclusionCriteria |
| Details |
Any chronic pain syndromes.
Chronic obstructive pulmonary disease.
Any history of hypersensitivity to opioids or patch additives.
Obstructive sleep apnoea.
Psychiatric disorders which impact on appropriate data collection.
Surgeries lasting for more than 2 hours.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesia will be assessed using numerical rating scale. |
2hr, 4hr, 12hr, 24hr,36hr, 48hr, 60hr, 72hr after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects like nausea, vomiting, pruritus, headache, diziness |
2hr, 4hr, 12hr, 24hr,36hr, 48hr, 60hr, 72hr after surgery |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
16/06/2017 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.Arshad Z, Prakash R, Gautam S, Kumar S. Comparison between transdermal buprenorphine and transdermal fentanyl for postoperative pain relief after major abdominal surgeries. Journal of clinical and diagnostic research: JCDR. 2015 Dec;9(12):UC01.
2.Kumar S, Chaudhary AK, Singh PK, Verma R, Chandra G, Bhatia VK, Singh D, Bogra J. Transdermal Buprenorphine Patches for Postoperative Pain Control in Abdominal Surgery. Journal of clinical and diagnostic research: JCDR. 2016 Jun;10(6):UC05.
3.Jose DE, Ganapathi P, Sharma NA, Shankaranarayana P, Aiyappa DS, Nazim M. Postoperative pain relief with epidural buprenorphine versus epidural butorphanol in laparoscopic hysterectomies: A comparative study. Anesthesia, essays and researches. 2016 Jan;10(1):82.
4.Vadivelu N, Hines RL. Buprenorphine: a unique opioid with broad clinical applications. Journal of opioid management. 2007;3(1):49-58. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Buprenorphine is a potent analgesic widely used for postoperative analgesia especially through the epidural route. Transdermal patches of buprenorphine provide an easy, safe and sustained method of drug delivery and avoids multiple pricks. This study tries to evaluate efficacy of transdermal buprenorphine in providing postoperative analgesia compared to epidural buprenorphine infusion. Side effects like headache, nausea, vomiting , respiratory depression , pruritis and dizziness will also be watched for. |