| CTRI Number |
CTRI/2017/05/008467 [Registered on: 03/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To find out whether sciatic nerve is blocked accidentally following pain relief nerve block for piles surgery |
|
Scientific Title of Study
|
randomised trial comparing the incidence of unintended sciatic nerve block following ultrasound guided pudendal nerve block with two different volumes of ropivacaine for hemorrhoidectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnagopal Vinod |
| Designation |
Associate professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Faculty Room,Department of Anaesthesiology,
Second Floor OT complex,
Shri Sathya Sai Medical college and Research Institute
Ammapettai,Sembakkam Post,Chengalpattu Taluk,Kancheepuram District
Department of Anaesthesiology,
Shri Sathya Sai Medical college and Research Institute,Tiruporur Guduvancherry road,
Ammapettai,Sembakkam Post,Chengalpattu Taluk.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnagopal Vinod |
| Designation |
Associate professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Faculty Room,Second Floor OT Complex,Department of Anaesthesiology,
Shri Sathya Sai Medical college and Research Institute
Ammapettai,Sembakkam Post,Chengalpattu Taluk,Kancheepuram District
Department of Anaesthesiology,
Shri Sathya Sai Medical college and Research Institute,Tiruporur Guduvancherry road,
Ammapettai,Sembakkam Post,Chengalpattu Taluk.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnagopal Vinod |
| Designation |
Associate professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Faculty Room,Second Floor OT complex,Department of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute Ammapettai,Sembakkam Post,Chengalpattu Taluk,Kancheepuram District
Department of Anaesthesiology,
Shri Sathya Sai Medical college and Research Institute,Tiruporur Guduvancherry,
Ammapettai,Sembakkam Post,Chengalpattu Taluk.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute,Tiruporur Guduvanchery Road,Ammapettai,Sembakkam Post-603108,Chengalpattu Taluk,Kancheepuram |
|
|
Primary Sponsor
|
| Name |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Tiruporur Guduvanchery road,Ammapettai,Kancheepuram |
| 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 |
| Krishnagopal Vinod |
Shri Sathya Sai medical college and research institute |
Department of Anaesthesiology,
Operation Theatre complex
Kancheepuram
TAMIL NADU |
04427440700
vinodkrishnagopal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri sathya sai medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients sufferring from hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pudendal nerve block under ultrasound guidance |
Perinueral injection given in the interligamentous plane blocking both the right and left pudendal nerve |
| Comparator Agent |
Two different volumes of local anaesthetic Ropivacaine |
Group I would recieve 10ml of 0.25% of Ropivcaine and Group II would recieve 5ml of 0.25% of Ropivacaine each side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients aged between 18 to 60 years posted for elective hemorrhoidectomy .
2) Patients belonging to ASA physical status I and II.
2) Willingness to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) ASA III and above.
2) Psychiatric illness.
3) Patients on anticoagulants .
4) Any neuropathic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the Incidence of unintended sciatic nerve block with two different volumes of ropivacaine |
1)Spread of drug to the sciatic nerve confirmed with ultrasound 2)Signs of motor or sensory involvement in the ditribution of sciatic nerve in the first 24 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Time of block would be taken as time zero,time of first analgesic requirement would be calculated in minutes from this point
2)Total demand of analgesics in 24 hours would be noted
3)The quality of pain relief would be assessed by NPRS numeric pain rating scale
4)Patients satisfaction was assessed by a three point scale excellent, satisfactory and unsatisfactory |
1)Time of block would be taken as time zero,time of first analgesic requirement would be calculated in minutes from this point
2)Total demand of analgesics in 24 hours would be noted
3)The quality of pain relief would be assessed by NPRS numeric pain rating scale
4)Patients satisfaction was assessed by a three point scale excellent, satisfactory and unsatisfactory |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
13/02/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
30 patients undergoing elective hemorrhoidectomy would be dived randomly divided into to two groups.Written informed consent would be obtained from the patient.All the patients would be fasted pre operatively for 6 hours.On the day of surgery ,the motor power and sensation of the sciatic nerve would be noted.An intravenous cannula would be started and the patient would be loaded with 10ml/kg RL.The patients vitals would be monitored and the patient would be place in the prone position.For patient belonging to group I ,the pelvis would be scanned with a 3-6 mega hertz ultrasound probe starting from the Posterior superior illiac spine and advanced down to identify the Greater sciatic foraman and the Piriformis.Once when the piriformis is identified then the probe is still moved caudally until the piriformis disappears and the sacrospinous and the sacrotuberous ligament is noted.The probe is adjusted such that the sciatic nerve is visualised lateral to the ischial spine and the pudendal nerve and artery is visualised medial to the ischial spine in the interligamentous plane.the neerdle is advanced under real time ultrasound guidance till the tip reaches the inter ligamentous plane medial to the pudendal artery.Once when the position is confirmed 10 ml of 0.25% of ropivacaine is injected incrementally after repeated aspiration for blood and the spread of injectate to the sciatic nerve would be noted.The same procedure would be repeated in the opposite side.For patients belonging to group II the same procedure would be repeated but the volume of 0.25% ropivacaine injected would be 5ml on each side.Following the block the patient would be turned to supine position and general anaesthesia induced and appropriate sized LMA would be inserted and the surgical procedure would be completed.After the procedure the patient would be reversed from general anaesthesia and the outcomes would be assessed. |