| CTRI Number |
CTRI/2020/03/023717 [Registered on: 03/03/2020] Trial Registered Prospectively |
| Last Modified On: |
15/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of low and high density local anaesthetic agent for one limb surgery |
|
Scientific Title of Study
|
Comparative evaluation of low dose hypobaric and hyperbaric bupivacaine for surgeries under unilateral spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asha Anand |
| Designation |
Associate Professor |
| Affiliation |
Punjab institute of medical sciences, Jalandhar |
| Address |
Department of Anaesthesia, Punjab institute of medical sciences jalandhar
Garha Road, Jalandhar
Jalandhar
PUNJAB
144006
India |
| Phone |
07973449563 |
| Fax |
|
| Email |
docsaasha2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asha Anand |
| Designation |
Associate Professor |
| Affiliation |
Punjab institute of medical sciences, Jalandhar |
| Address |
Department of Anaesthesia, Punjab institute of medical sciences jalandhar
Garha Road, Jalandhar
Jalandhar
PUNJAB
144006
India |
| Phone |
07973449563 |
| Fax |
|
| Email |
docsaasha2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ArwinderPal Singh |
| Designation |
Associate Professor |
| Affiliation |
Punjab Institute of Medical sciences |
| Address |
Department of Anaesthesia, Punjab institute of Medical Sciences,
Garha Road, Jalandhar
Jalandhar
PUNJAB
144006
India |
| Phone |
07973449563 |
| Fax |
|
| Email |
arwin79@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Punjab Institute of Medical Sciences Jalandhar |
|
|
Primary Sponsor
|
| Name |
Punjab Institute of Medical Sciences |
| Address |
Dept of Anaesthesia, Punjab Institute of Medical Sciences, Jalandhar, Punjab |
| 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 |
| Asha Anand |
Operation Theatre Complex |
Department of Anaesthesia Punjab institute of medical sciences jalandhar
Garha Road, Jalandhar
Jalandhar
PUNJAB |
7973449563
docsaasha2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pims institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S82||Fracture of lower leg, including ankle, (2) ICD-10 Condition: M972||Periprosthetic fracture around internal prosthetic ankle joint, (3) ICD-10 Condition: M173||Unilateral post-traumatic osteoarthritis of knee, (4) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (5) ICD-10 Condition: S823||Fracture of lower end of tibia, (6) ICD-10 Condition: S910||Open wound of ankle, (7) ICD-10 Condition: S880||Traumatic amputation at knee level, (8) ICD-10 Condition: S830||Subluxation and dislocation of patella, (9) ICD-10 Condition: S831||Subluxation and dislocation of knee, (10) ICD-10 Condition: S878||Crushing injury of lower leg, (11) ICD-10 Condition: S870||Crushing injury of knee, (12) ICD-10 Condition: S930||Subluxation and dislocation of ankle joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 ml (5mg) of 0.5% hyperbaric bupivacaine and 2 ml of 0.25%(5 mg) hypobaric bupivacaine |
Unilateral Spinal Anaesthesia with hyperbaric and hypobaric Bupivacaine for lower limb surgeries |
| Intervention |
comparison of hypobaric Bupivacaine and hyperbaric bupivacaine for unilateral spinal anaesthesiae |
In the intervention Unilateral spinal anaesthesia will be given with hyperbaric bupiivacaine in one group and hypobaric bupivacaine in second group. Then these will be compared in terms of time required to achieve sensory and motor blockade and patient satisfaction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Sixty patients of either sex, ASA grade I-III, aged between 18-65 years posted for unilateral lower limb surgeries. Procedures lasting for maximum duration of 60 minutes will be included. |
|
| ExclusionCriteria |
| Details |
1. Hypovolemia,
2. Preexisting Neurological Disease,
3. Coagulation Disorders,
4. Administration of thromboprophylaxis less than eight hours prior to the surgery
5. Infection At The Puncture site,
6. Agitation And Delirium,
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy of the Blockade
2. Haemodynamic Stability
3. Anaesthesia onset and offset time,
4. Patient satisfaction
|
1.Immediately after spinal anaesthesia
2. At 15 min interval during surgery
3.At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects related to drugs ie Bradycardia
Hypotension
Nausea and Vomiting |
1. During surgery
2. 2 hours after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/03/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hyperbaric bupivacaine is used for unilateral spinal anaesthesia .This is performed in lateral position and side to be operated to be down. Unilateral spinal anaesthesia with hypobaric bupivacaine is given with side to be operated upwards. this helps in making patient proper position and also there is no need of turning patient back for the start of surgery.So in this study we will compare low dose hypobaric and and hyperbaric bupivacaine for unilateral spinal anaesthesia in terms of efficacy of blockade, haemodynamic stability, anaesthesia onset and offset time and patient satisfaction. |