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CTRI Number  CTRI/2023/08/055980 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 31/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing buprenorphine and fentanyl as additives to intrathecal ropivacaine under spinal anaesthesia  
Scientific Title of Study   Comparing the effects of intrathecal buprenorphine versus fentanyl as adjuvant to hyperbaric ropivacaine in lower limb surgeries  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Katuri Srilakshmi  
Designation  Junior Resident 
Affiliation  KS HEGDE MEDICAL ACADEMY  
Address  Department of Anesthesiology and Critical care, KS Hegde medical academy, Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8008283176  
Fax    
Email  srilukaturi31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gayathti Bhat 
Designation  Professor  
Affiliation  KS HEGDE MEDICAL ACADEMY  
Address  Department of Anesthesiology and Critical care, KS Hegde medical academy, Deralakatte Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8008283176  
Fax    
Email  gaibhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Katuri Srilakshmi  
Designation  Junior Resident 
Affiliation  KS HEGDE MEDICAL ACADEMY  
Address  Department of Anesthesiology and Critical care, KS Hegde medical academy, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8008283176  
Fax    
Email  srilukaturi1996@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical care, KS Hegde medical academy  
 
Primary Sponsor  
Name  Department of Anesthesiology  
Address  KS Hegde medical academy,Deralakatte, Mangalore 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Katuri Srilakshmi   KS HEGDE MEDICAL ACADEMY   Department of Anesthesiology and Critical care, KS Hegde medical academy
Dakshina Kannada
KARNATAKA 
8008283176

srilukaturi31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, KS HEGDE MEDICAL ACADEMY   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA 1-2 undergoing lowerlimb surgeries under spinal anaesthesia  
 
ExclusionCriteria 
Details  Bleeding disorders
Local skin infections
Raised intracranial pressure
Morbid obesity
Height less than 150cm
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Buprenorphine & Fentanyl when given intrathecally as an adjuvant to hyperbaric ropivacaine in terms of
1. Sensory blockade
2. Motor blockade
3. Incidence of bradycardia
Incidence of hypotension  
The sensory & motor block levels assessment was performed at 5 mins interval for the first 15mins then 15 mins interval for half an hour followed postoperative room (first one hour of shifting)
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare buprenorphine & fentanyl when given intrathecally as an adjuvant to hyperbaric ropivacaine in terms of
1. Incidence of nausea and vomiting
2. Incidence of pruritis and other side effects 
Nausea, vomiting, post operative pain & pruritis will be assessed hourly in post operative unit upto 12 hours 
 
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   N/A 
Date of First Enrollment (India)   10/08/2023 
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="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Spinal anaesthesia is a widely used technique in anaesthetic practice for gynaecological, lower abdominal, pelvic and lower limb surgeries. Spinal anaesthesia offers certain advantages such as:
● It ensures high patient satisfaction
● Cost effective
● Requires lesser duration of hospital stay
● Has decreased incidence of nausea and vomiting
Though subarachnoid block is widely used for lower limb surgeries, it has practical limitations in prolonged surgeries.1 To prolong the duration of sensory-motor block and limiting the cumulative dose requirement of local anaesthetics, co-administration of adjuvants has the potential to improve efficacy of subarachnoid blocks and decrease local anaesthetic toxicity.2 Various drugs such as morphine, pethidine, phenylephrine, neostigmine, ketamine, and many others have been used. Among these buprenorphine and fentanyl are also tried as an adjuvant to LAs to prolong the anaesthetic effects of LAs.

After approval from the Institutional Ethics Committee, participants will be explained about the nature of the study and written informed consent will be obtained. A thorough pre-anaesthetic evaluation will be done a day prior to the surgery. All patients will be kept nil per oral 8 hours for solids and 2 hours for clear liquids.
Patients will be shifted to the operation theatre after preoperative monitoring of vitals and confirming the NPO status of patient. Standard monitors will be attached including electrocardiography, peripheral oxygen saturation and noninvasive blood pressure monitor. All the basal parameters will be recorded. All patients will be coloaded with Ringer’s lactate solution 10 ml/kg body weight. Under strict aseptic conditions, subarachnoid block will be performed at L3-L4 inter vertebral space through midline approach using a 25gauge Quincke-Babcock spinal needle. After ensuring the free flow of clear CSF, patient will be given intrathecal 3 ml of 0.75% ropivacaine heavy along with 0.5 ml of buprenorphine or 0.5 ml of fentanyl as adjuvant according to the preference of concerned anaesthesiologist.

The sensory and motor block levels assessment was performed at 5 mins interval for the first 15mins then 15 mins interval for half an hour followed postoperative room (first one hour of shifting)

1.SENSORY BLOCK:
Onset of sensory block will be taken as the time from injection of the study drug in the subarachnoid space until the time when maximum sensory level is achieved. The sensory blockade will be assessed with bilateral cold spirit swab method. The highest dermatome showing sensory analgesia will be taken as the upper segmental level of block when it remained same even after 5 min. Total duration of sensory block will be taken as an interval from intrathecal administration of the study drug to regression of sensory block to S1 level.
2.MOTOR BLOCKADE:
The degree of motor block will be assessed by the modified Bromage Scoring System.
3.HEMODYNAMIC CHANGES
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) will be recorded every 3 mins interval for the first 12mins then 5 mins interval for 30mins followed by every 15mins for another 30min and then post operatively hourly for two hours.
4.POST OPERATIVE PAIN:
Post operative pain is assessed every 30 mins till the first 2 hrs and then every 2 hrs till 24 hrs or once patient complaints of pain according to NRS scale. NRS will be explained to the patient. NRS is a segmented numerical version of the visual analogue score (VAS) in which the respondent selects a whole number that best reflects the intensity of his/her pain. It is an elevenpoint scale ranging from 0 to 10 where 0 represents no pain and 10 meaning the worst imaginable pain.
5.ADVERSE EFFECTS IF ANY:
Complications such as nausea, vomiting, urinary retention, shivering will also be noted and treated appropriately

Once the required data is collected, patients who received 0.5 ml buprenorphine as adjuvant to intrathecal ropivacaine heavy will be termed as Group B and patient who received 0.5 ml fentanyl as an adjuvant will be termed as Group F.



 
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