| CTRI Number |
CTRI/2012/05/002623 [Registered on: 04/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between an injection used for treating vomiting and acupressure bands on the wrist for controlling nausea and vomiting during and following anesthesia |
|
Scientific Title of Study
|
A comparative study of P6 acupressure and intravenous ondansetron for prevention of postoperative nausea and vomiting following intrathecal buprenorphine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sidhesh Bharne |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
F1/A2 kurtarkar vatika shantinagar ponda
North Goa
GOA
403 401
India |
| Phone |
9923953171 |
| Fax |
|
| Email |
sbharne@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Dsouza |
| Designation |
Consultant |
| Affiliation |
Goa Medical College |
| Address |
Dept of Anesthesiology,
Goa Medical College,
Bambolim, Goa
North Goa
GOA
403 602
India |
| Phone |
9822159170 |
| Fax |
|
| Email |
shirley_dsouza05@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sidhesh Bharne |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
F1/A2 kurtarkar vatika shantinagar ponda
North Goa
GOA
403 401
India |
| Phone |
9923953171 |
| Fax |
|
| Email |
sbharne@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Goa Medical College |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Goa Medical College
Bambolim
Goa |
| 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 Sidhesh Bharne |
Department of Anesthesiology |
Goa Medical College
Bambolim
Goa
North Goa
GOA |
9923953171
sbharne@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
post operative nausea and vomiting, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupressure wrist band |
The acupresssure band is to be worn on the wrist, with the pressure button on the flexor surface, 4 cm proximal to the wrist crease, 30 minutes prior to induction of anesthesia. it is to be kept for 6 hours following surgery. 4 ml saline is also given IV 30 minutes before induction |
| Comparator Agent |
Control |
sham(false) band + 2 ml saline 30 minutes before induction |
| Comparator Agent |
Ondansetron (intravenous) |
4 mg IV given 30 minutes prior to induction of anesthesia. Sham (false) band is placed 30 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA class I or II patients
2) Requiring orthopaedic surgery of the lower limbs under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1) Gastrointestinal disorders
2) Major systemic disease (ASA class III or more)
3) Obesity
4) Carpal tunnel syndrome and any deformity at the wrist
5) Known allergy to any of the study drugs
6) Contraindications to neuraxial blocks
7) On antiemetic drugs
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
P6 acupressure is effective in preventing post operative nausea and vomiting following intrathecal buprenorphine
P6 acupressure is not effective in preventing post operative nausea and vomiting following intrathecal buprenorphine |
intraoperative period, post operative period upto 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any possible adverse effects of acupressure compared with ondansetron |
intraoperative and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/04/2012 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
120 patients fulfilling the above criteria will be included after written, informed consent. they will be randomly divided into 3 groups of 40 each named A, B, and C. Group A : acupressure group, Group B: 4 mg IV ondansetron group, and group C control. All patients will receive 2.8 to 3 ml of 0.5% heavy bupivacaine + 150 mcg buprenorphine in spinal anesthesia. all will maintain their bands/ sham bands for 24 hours postop and will be observed for occurrence of PONV
|