| CTRI Number |
CTRI/2021/08/035540 [Registered on: 09/08/2021] Trial Registered Prospectively |
| Last Modified On: |
08/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effects of mixed versus sequential adminstration of levobupivacaine and fentanyl in spinal anaesthesia for leg surgeries. |
|
Scientific Title of Study
|
Comparison of effects of mixed versus sequential adminstration of levobupivacaine and fentanyl in subarachnoid block for lower limb surgeries:A randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shameer imam |
| Designation |
Pg 1st year Anaesthesia |
| Affiliation |
School of Medical Sciences and Research,Greater Noida. |
| Address |
Department of Anesthesiology
School Of Medical Sciences And Research.
Sharda university
Plot 32,34 Apj Abdul Kalam Road
Knowledge Park3,Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8127553526 |
| Fax |
|
| Email |
shamimam00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsh Vardhan |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
School of Medical Sciences and Research,Greater Noida. |
| Address |
Department of Anesthesiology
School Of Medical Sciences And Research
Sharda university
Plot 32,34 Apj Abdul Kalam Road
Knowledge Park3,Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9871952687 |
| Fax |
|
| Email |
harshvardhan23@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Vardhan |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
School of Medical Sciences and Research,Greater Noida. |
| Address |
Department of Anesthesiology
School Of Medical Sciences And Research
Sharda university
Plot 32,34 Apj Abdul Kalam Road
Knowledge Park3,Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9871952687 |
| Fax |
|
| Email |
harshvardhan23@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharda hospital |
| Address |
School of Medical Sciences & Research
Plot No. 32, 34, APJ Abdul Kalam Rd, Knowledge Park III, Greater Noida,
Uttar Pradesh
201310 |
| 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 |
| Shameer imam |
Sharda hospital school of medical science and research |
Department of Anesthesiology 2nd Floor B block
Sharda hospital school of medical science and research
Gautam Buddha Nagar
UTTAR PRADESH |
8127553526
shamimam00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine |
Effect of Levobupivacaine and fentanyl when given in sequence or as a mixture for subarachnoid block will be studied in lower limb surgeries. |
| Comparator Agent |
Levobupivacaine and fentanyl |
Group A patients will receive mixed 0.5% isobaric levobupivacaine 3 ml (15 mg) and 0.5 ml (25 microgram) of fentanyl in a single 5.0 ml syringe.
Group B patients will receive 0.5 ml (25 microgram) of fentanyl in a 3.0 ml syringe followed by 3 ml of 0.5% isobaric levobupivacaine in a 5 ml syringe and
Group C will receive 3ml of 0.5% isobaric levobupivacaine in a 5ml syringe followed by 0.5 ml (25 microgram) of fentanyl in a 3 ml syringe.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18-65 years.
American Society of Anaesthesiologists (ASA) grade I&II
Scheduled for lower limb surgeries under subarachnoid block
|
|
| ExclusionCriteria |
| Details |
1)Patient refusal to participate in the study
2)Any History of allergy to the study medication
3)Any history of clotting or bleeding disorder
4)Infection at the site of lumbar puncture
5)Patients with pre existing neurological deficit
6)Any history of psychiatric illness
Pregnant patients |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare subarachnoid block characteristics after mixed versus sequential administration of levobupivacaine and fentanyl for lower limb surgeries.
2.To compare intraoperative hemodynamic parameters between the three groups.
|
1)Sensory block was assessed by a sterile pin prick every 2 min till 20 min and then after every 10 min till the highest level was achieved.
2)Onset was defined as the loss of sensation at T10 dermatome. The time to onset of motor block was defined as time taken to reach Modified Bromage score of 4.
3)Time of regression of motor block was assessed as time to reduce to from maximum attained Modified Bromage score to score of 0. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the duration of postoperative analgesia between the three groups.
2.To evaluate opioid related side effects in the three groups.
|
Analgesia remaining in the postoperative period will be assessed by VAS scale at hourly intervals for eight hours after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
14/08/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Subarachnoid block is the most commonly used anaesthesia technique for lower limb surgeries. Opioids are the most commonly used adjuvants with local anesthetics (LA). Adjuvants are given premixed with LA loaded in a single syringe. This study was conducted to evaluate differences in characteristics of sensory and motor block,hemodynamic parameters and post operative pain whilst administering isobaric Levobupivacaine and fentanyl either in a single syringe or different syringes. The effect of administering opioid prior to LA and vice versa on these parameters was also assessed. Methods: One hundred and twenty patients were randomly allocated into three groups of 40 each: Group A received premixed 0.5% isobaric levobupivacaine 3 ml (15 mg) and 0.5 ml (25 microgram) of fentanyl in a single 3.0 ml syringe, Group B received 0.5 ml (25 microgram) of fentanyl in a 3.0 ml syringe followed by 0.5% isobaric levobupivacaine 3ml (15 mg) in a 3.0 ml syringe, Group C received 0.5% isobaric levobupivacaine 3ml (15 mg) in a 3.0 ml syringe followed by 0.5 ml (25 microgram) fentanyl in a 3.0 ml syringe. All statistical calculations were done using SPSS 21 version statistical program for Microsoft Windows. |