CTRI Number |
CTRI/2021/09/036808 [Registered on: 24/09/2021] Trial Registered Prospectively |
Last Modified On: |
22/09/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study to compare two drugs when added to levobupivacaine in lower limb surgeries |
Scientific Title of Study
|
A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to 0.5% levobupivacaine in lower limb surgeries: A randomised double blind 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 Gulwatan Singh Kang |
Designation |
Junior Resident |
Affiliation |
Rohilkhand medical college and hospital |
Address |
Rohilkhand medical college and hospital, Bareilly, UP, India
Bareilly UTTAR PRADESH 243006 India |
Phone |
7986561752 |
Fax |
|
Email |
gulwatansingh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Neeharika Arora |
Designation |
Professor |
Affiliation |
Rohilkhand medical college and hospital |
Address |
Department of Anaesthesia, Rohilkhand medical college and hospital, Bareilly, UP, India
Bareilly UTTAR PRADESH 243006 India |
Phone |
8077104070 |
Fax |
|
Email |
docneehars@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Neeharika Arora |
Designation |
Professor |
Affiliation |
Rohilkhand medical college and hospital |
Address |
Department of Anaesthesia, Rohilkhand medical college and hospital, Bareilly, UP, India
Bareilly UTTAR PRADESH 243006 India |
Phone |
8077104070 |
Fax |
|
Email |
docneehars@gmail.com |
|
Source of Monetary or Material Support
|
Rohilkhand medical college and hospital |
|
Primary Sponsor
|
Name |
Rohilkhand medical college and hospital |
Address |
Bareilly, Uttar Pradesh, India |
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 |
Dr Gulwatan Singh Kang |
Rohilkhand medical college and hospital |
Department of Anaesthesiology, Main OT Complex, Room no. 2062 Bareilly UTTAR PRADESH |
7986561752
gulwatansingh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee (IEC) , Rohilkhand medical college Bareilly Uttar Pradesh |
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 |
Intervention |
Dexmedetomidine (3 mcg) and 0.5% levobupivacaine (15 mg) intrathecally |
Dexmedetomidine is aplha-2 agonist used as adjuvant Levobupivacaine is local anaesthetic agent |
Comparator Agent |
Fentanyl (15 mcg) and 0.5% Levobupivacaine (15 mg) intrathecally |
Fentanyl is opioid used as adjuvant. Levobupivacaine is local anaesthetic agent |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
ASA I or II
Age between 19 to 65 years
Either sex
Patient posted for elective lower limb surgery |
|
ExclusionCriteria |
Details |
Patient refusal for procedure
Patient’s contraindications to spinal anaesthesia (eg: deranged coagulation profile )
Obesity (BMI>30kg/m2)
Any neuropathies
Patients receiving Opioids for chronic analgesic therapy
Allergy or intolerance to local anaesthetics
Patients on beta-blocker or known dysrhythmia |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Onset and duration of motor and sensory blockade |
On Day 1 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Haemodynamic changes , post - op shivering and emesis |
On Day 1 |
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
01/10/2021 |
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="0" 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
|
Spinal anaesthesia is popular and commonly used worldwide. It is economical and easy to administer and thus, commonly used technique for lower limb orthopaedicsurgeries. The advantages of a minimal drug costs, awake patient and rapid patient turnover has made this the method of choice for many surgical procedures.2 Post operative pain is common problem during lower limb orthopaedic surgeries under spinal anesthesia because spinal anesthesia using only local anesthetics is associated with relatively limited duration of action, and thus early analgesic intervention is needed in the postoperative period. So number of adjuvants, such as clonidine, fentanyl, dexmedetomidine and midazolam have been studied to prolong the spinal anesthesia effect.3 Dexmedetomidine and fentanyl are promising adjuncts to provide excellent and prolonged postoperative analgesia.5 Fentanyl is a potent synthetic opioid analgesic which is short-acting and highly lipophilic. It has been commonly used as an adjuvant to bupivacaine for postoperative analgesia.1 Few studies have been done with fentanyl and dexmedetomidine as an adjuvant to levobupivacaine in obstetric patients. We have not come across any study on use of fentanyl and dexmedetomidine in lower doses as an adjuvant to levobupivacaine. Hence, in this study we propose to compare a combination of isobaric levobupivacaine with fentanyl versus dexmedetomidine in low dose for the characteristics of spinal blockade with respect to onset, duration and hemodynamic parameters and side effect. |