| CTRI Number |
CTRI/2014/09/005037 [Registered on: 18/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
01/08/2016 |
| 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
|
EVALUATION OF EFFECT OF BLOWING IN A PIPE CONNECTED WITH BLOOD PRESSURE MEASURING DEVICE FOR REDUCING LUMBAR PUNCTURE BACK PAIN |
|
Scientific Title of Study
|
EVALUATION OF EFFICACY OF VALSALVA FOR ATTENUATING LUMBAR PUNCTURE PAIN |
| Trial Acronym |
EVALP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Agarwal |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Type-5B/11, SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904589 |
| Fax |
0522-2668017 |
| Email |
anil_sgpgi@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Type 4/68, SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904045 |
| Fax |
0522-2668017 |
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Agarwal |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Type-5B/11, SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904589 |
| Fax |
0522-2668017 |
| Email |
anil_sgpgi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute Of Medical Sciences, Lucknow-226014
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences |
| Address |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences, Lucknow-226014
Uttar Pradesh
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anil Agarwal |
Department of Anaesthesiology |
SGPGIMS, Lucknow-226014
Lucknow
UTTAR PRADESH |
8004904589
0522-2668017
anil_sgpgi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sgpgi, lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy or mild functional limitation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I ( Control) |
Acted as control and did not perform valsalva nor blew through a open tube |
| Comparator Agent |
Group II (Distraction) |
Patients were asked to blow through a rubber tube not connected to sphygmomanometer |
| Intervention |
Group III(Valsalva) |
Patients were asked to blow into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec. During the valsalva spinal puncture would be performed with a 26 G spinal needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult(ASA grade I and II)of age group 18-75yrs. |
|
| ExclusionCriteria |
| Details |
Patients having problems in communication, abnormal skin condition such as infection at the site of proposed lumber puncture, scars, eczema, obese patients, history of previous spinal surgery, patient’s refusal for spinal, patients requiring > 1 attempt for successful spinal or change of inter vertebral space. Patients who could not hold the mercury column up to 30 mmHg for a period of at least 20 seconds |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of valsalva procedure in attenuating the lumber puncture pain |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of valsalva procedure on CSF flow
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims and objectives: Primary objective: To evaluate the efficacy of valsalva procedure in attenuating the lumber puncture pain Secondary objective: To evaluate the efficacy of valsalva procedure on CSF flow Methodology: Patients will be randomized with the help of a computer-generated table of random numbers into 3 groups of 30 each. Group I (Control): acted as control and did not perform valsalva nor blew through a open tube; group II (Distraction): patients were asked to blow through a rubber tube not connected to sphygmomanometer; Group III (Valsalva): patients were asked to blow into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec. During the valsalva spinal puncture would be performed with a 26 G spinal needle. Exclusion: obese patients, history of previous spinal surgery, patient’s refusal for spinal, patients requiring > 1 attempt for successful spinal or change of inter vertebral space Risks associated with the procedure are none as in ASA 1 and 2 patients; however, valsalva procedure has been reported to attenuate pain in animal studies and more so in humans for minimizing venous cannulation pain in adults and paediatric patients. We therefore wish to evaluate its efficacy in attenuating the lumber puncture pain. |