| CTRI Number |
CTRI/2024/07/070698 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of heavy Ropivacaine versus
heavy Levobupivacaine during day care
surgery under spinal anaesthesia
|
|
Scientific Title of Study
|
Comparison of hyperbaric Ropivacaine versus
hyperbaric Levobupivacaine during day care
surgery under subarachnoid block
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tulika Singh |
| Designation |
Post graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5,GMCH, Sector 32B, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9530701884 |
| Fax |
|
| Email |
tulikakv2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasveer Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5,GMCH, Sector 32B, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
drjassy18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasveer Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5,GMCH, Sector 32B, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
drjassy18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, sector 32B, Chandigarh, 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, sector 32B, Chandigarh, 160030 |
| 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 Tulika Singh |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, sector 32B, Chandigarh
Chandigarh
CHANDIGARH |
9530701884
tulikakv2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Levobupivacaine |
Single injection of Hyperbaric Levobupivacaine 3ml in the subarachnoid space producing subarachnoid block with duration of 2-2.5hrs |
| Intervention |
hyperbaric Ropivacaine |
Single injection of Hyperbaric Ropivacaine 3ml in the subarachnoid space producing subarachnoid block with duration of 2-2.5hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18-65 years
American Society of Anaesthesiologists (ASA) physical status I and II of either sex
BMI ≥ 20 to ≤ 35kg/m2
Duration of surgery upto 2-2.5 hours in day care surgery (lower abdominal and
perineal surgery) |
|
| ExclusionCriteria |
| Details |
Pre-existing local infection at the site of subarachnoid block
Patients with coagulopathy and platelet disorders.
Contraindication or allergy to study drugs
Patients having pain in any other area than the surgery site
Patients having sensory or motor problem in the lower limb
Patients who failed to understand the VAS scoring system
Pregnant and lactating women
Patients with current history of psychiatric illness, communication difficulties |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of duration of motor block after
injecting the drugs intrathecally.
Assessment of sensory block will be done using
sterile pin prick method and motor block will be
assessed using Modified Bromage scale. Hemodynamics will be assessed. |
Sensory and motor block is assessed every minute for 10 mins and thereafter every 10 mins during surgery and post operatively every 15mins. Hemodynamics every 5mins after spinal anaesthesia till 15mins and then every 15mins till reversal of block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of onset of sensory and motor
block, peak level, time to 2 segment regression,
duration of effective analgesia and any side
effects of drug or procedure |
Sensory and motor blockade will be
assessed every minute for the first 10 minutes
and thereafter every 10 mins during surgery
and every 15 minutes postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/07/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 76 patients undergoing elective surgery will be randomly allocated to two groups of 38 patients each using computer generated random number table and the allotted number will be secured in a coded opaque sealed envelope. The patients will be allocated to one of the following two groups: Group R (n=38): Patients will be given 3ml of 0.75% Hyperbaric Ropivacaine intrathecally Group L (n=38): Patients will be given 3ml of 0.5% Hyperbaric Levobupivacaine intrathecally Procedure on day of surgery: Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, continuous electrocardiogram, respiratory rate, and oxygen saturation (Spo2). Baseline values will be recorded. After subarachnoid block has been given, assessment of sensory block will be done using sterile pin prick method and motor blockade will be done using Modified Bromage scale. Assessment will be done every minute for the first 10 minutes and then every 10 minutes during surgery and every 15 minutes postoperatively. Onset of both motor and sensory blockade will be assessed and recorded. The highest dermatomal level of sensory blockade and recovery time of both sensory and motor blockade will be recorded. Recovery time for the sensory blockade will be defined as the two dermatome regression of anaesthesia from the maximal level. Patients will receive rescue analgesia accordingly. The time of first request for analgesia postoperatively will be recorded as total duration of spinal analgesia. Patient will be monitored continuously intra and post operatively and observations will be recorded in the prescribed proforma. |