| CTRI Number |
CTRI/2010/091/000249 [Registered on: 30/03/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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A clinical trial to examine whether administering a low dose spinal anesthesia along with general anesthesia will give better pain relief in patients undergoing laparoscopic hernia repair. |
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Scientific Title of Study
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ANALGESIC EFFICACY OF LOW DOSE SPINAL BUPIVACAINE WITH FENTANYL FOR LAPAROSCOPIC HERNIA REPAIR ?A RANDOMIZED CONTROLLED STUDY
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
S.Rajeshwari |
| Designation |
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| Affiliation |
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| Address |
Room no.5010-D,Deptt of Anesthesiology
Teaching Block, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126193120 |
| Fax |
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| Email |
drsrajeshwari@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
S.Rajeshwari |
| Designation |
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| Affiliation |
MD(Anesthesiology),Professor |
| Address |
Room no.5010-D,Deptt of Anesthesiology
Teaching Block, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126193120 |
| Fax |
|
| Email |
drsrajeshwari@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
S.Rajeshwari |
| Designation |
|
| Affiliation |
|
| Address |
Room no.5010-D,Deptt of Anesthesiology
Teaching Block, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126193120 |
| Fax |
|
| Email |
drsrajeshwari@gmail.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
S.Rajeshwari |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| S.Rajeshwari |
All India Institute of Medical Sciences |
Aurobindo Marg,Ansari Nagar-110029
New Delhi
DELHI |
09810079229
drsrajeshwari@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Inguinal hernia, laparoscopic repair, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Infiltration of skin on back with local anesthetic |
2 ml plain lignocaine 1% |
| Intervention |
Low dose subarachnoid block after skin infiltration with 1% plain lignocaine |
5 mg bupivacaine and 25mics fentanyl |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
(i) Adult males,Age 20 ? 65 years
(ii) Unilateral or bilateral reducible inguinal herniae
(iii) Scheduled for Total Extra Peritoneal (TEP) repair under geneal anesthesia
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| ExclusionCriteria |
| Details |
(i) Uncontrolled systemic illness
(ii) Neurological illness (Parkinsonism, h/o CVA)
(iii) Any contraindications to spinal anaesthesia (local infection, coagulopathy, documented anatomical abnormality, allergy to local anaesthetic agents)
(iv) Patients undergoing Trans Abdominal Pre Peritonal(TAPP)repair
(v) Irreducible herniae
(vi) Patients with other surgical procedures performed concurrently
(vii) Patient refusal for the study
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| 1) Incidence of pain after laparoscopic hernia repair
2)Intra- and post operative opioid sparing effect of low dose spinal anesthesia
3)Quality of recovery -effect of low dose spinal anesthesia |
Post operatively, 6 hourly, for 24 hours |
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Secondary Outcome
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| Outcome |
TimePoints |
| 1) Intra operative hemodynamic stability
2) Post operative nausea and vomiting
3) Side effects related to sub arachnoid block |
Intra operative and up to 24 hours post operatively |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a randomized, prospective, placebo controlled, parallel group study comparing general anesthesia alone with general anesthesia and 'add on' low dose spinal anesthesia in patients undergoing laparoscopic hernia repair.The primary outcome measures will be intra operative and post operative fentanyl sparing effect of spinal anesthesia, and effect on quality of recovery.Secondary outcome measures will be intra operative hemodynamic stability and post operative nausea and vomiting.Patients will be followed for 24 hours post operatively.All patients will have access to a patient-controlled analgesia (PCA) device which they can activate to get bolus doses of IV fentanyl. |