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CTRI Number  CTRI/2023/03/051043 [Registered on: 24/03/2023] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   EFFICIENCY OF DRUGS LIKE FENTANYL AND CLONIDINE WHEN ADDED AS ADJUVANTS TO PREVENT REBOUND PAIN IN PATIENTS UNDERGOING ANORECTAL SURGERIES UNDER SADDLE BLOCK. 
Scientific Title of Study   TO COMPARE THE EFFICACY OF CLONIDINE AND FENTANYL AS ADJUVANTS TO HYPERBARIC 0.5% BUPIVACAINE ON PREVENTION OF REBOUND PAIN IN ANORECTAL SURGERIES UNDER SADDLE BLOCK. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AZBAH MOHD HUSSAIN ANSARI 
Designation  JUNIOR RESIDENT 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS HOSPITAL

Mysore
KARNATAKA
570004
India 
Phone  9663831969  
Fax    
Email  azbah16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MURUGESH WALI 
Designation  ASSOCIATE PROFESSOR 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANESTHESIOLOGY, JSS HOSPITAL

Mysore
KARNATAKA
570004
India 
Phone  9945433173  
Fax    
Email  murugeshwali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRMURUGESH WAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  DEPARTMENT OF ANESTHESIOLOGY, JSS HOSPITAL

Mysore
KARNATAKA
570004
India 
Phone  9945433173  
Fax    
Email  murugeshwali@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  JSSAHER 
Address  JSS MEDICAL COLLEGE AND HOSPITAL, MYSORE 
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 AZBAH MOHD HUSSAIN ANSARI  JSS MEDICAL COLLEGE AND HOSPITAL  3rd FLOOR OT COMPLEX, MG ROAD, AGRAHARA
Mysore
KARNATAKA 
9663831969

azbah16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5mg 0.5% (H) Bupivacaine with 0.3ml Normal Saline  Spinal anaesthesia will be performed at either the L3-L4 or L4-L5 interspace through a midline approach using 25G Quincke’s spinal needle. After verification that CSF is freely flowing from the hub, 5mg of 0.5%(H) Bupivacaine with 3ml of Normal Saline will be injected for 10 secs. After the injection, patient will be seated for 10mins and will then be moved to lithotomy position.  
Comparator Agent  5mg 0.5%(H) Bupivacaine with 15mcgs Fentanyl   Spinal anaesthesia will be performed at either the L3-L4 or L4-L5 interspace through a midline approach using 25G Quincke’s spinal needle. After verification that CSF is freely flowing from the hub, 5mg of 0.5%(H) Bupivacaine with 15mcgs of Fentanyl will be injected for 10 secs. After the injection, patient will be seated for 10mins and will then be moved to lithotomy position.  
Comparator Agent  5mg 0.5%(H) Bupivacaine with 30mcgs Clonidine  Spinal anaesthesia will be performed at either the L3-L4 or L4-L5 interspace through a midline approach using 25G Quincke’s spinal needle. After verification that CSF is freely flowing from the hub, 5mg of 0.5%(H) Bupivacaine with 30mcgs of Clonidine will be injected for 10 secs. After the injection, patient will be seated for 10mins and will then be moved to lithotomy position.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -Patients posted for anorectal surgeries.
-Ability to understand protocol and able to provide voluntary written consent.
-ASA category I and II.
-BMI< 30kg/m2.
-Height 150-170cms.
 
 
ExclusionCriteria 
Details  -Uncontrolled psychiatric disorders.
-Uncontrolled medical illnesses like uncontrolled diabetes mellitus, uncontrolled hypertension, ischemic heart disease and chronic kidney disease.
-Any contraindication to clonidine i.e. bradycardia.
-Any contraindication to spinal anesthesia like patient refusal, infection at lumbar puncture site, coagulopathies or patients who are on anticoagulants.
-Allergic to local anaesthetics.
-Pregnant and lactating mothers.  
 
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 
To compare the efficacy of clonidine and fentanyl as adjuvants to hyperbaric 0.5% bupivacaine on prevention of rebound pain in anorectal surgeries under saddle block.  Starting from spinal anaesthesia till 48hours after completion of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
-To evaluate the post operative pain scores (NRS) for the first 48 hours after surgery after the administration of intrathecal adjuvants such as clonidine and fentanyl in patients undergoing anorectal surgery under saddle block .
-To assess the time taken for first rescue analgesic.
-To assess the total dose of rescue analgesic requirement for 48 hours post surgery.
-To assess the incidence of side effects between the groups receiving hyperbaric bupivacaine alone and in combination with fentanyl and clonidine. 
Starting from spinal anaesthesia till 48hours 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)   27/03/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Following approval from the Institutional Ethical Committee, informed and written consent will be taken from 120 patients undergoing elective anorectal surgeries such as hemorrhoidectomyfistulectomyfissurectomy, perianal abscess, pilonidal sinus excision, etc.


A thorough preanaesthetic evaluation will be done 24 hours prior to the procedure. The study will include patients posted for anorectal surgeries. Standard monitoring with electrocardiography (ECG), automated noninvasive blood pressure (NIBP), and pulse oximetry (SpO2) using multipara meter Philips Intellivue MP20/MP30 monitor will be done for baseline values and intraoperative monitoring.

 

The 120 patients will be randomly divided into three groups using shuffled sealed opaque envelope technique. The anaesthesiologist who will be involved in randomization also will be preparing the studied drugs. He will not be involved further in the study.

Group BF â€“ 40 patients will receive 5mg 0.5%(H) bupivacaine(1ml) with Fentanyl 15mcgs(0.3ml) intrathecally.

Group BC-  40 patients will receive 5mg 0.5%(H) bupivacaine(1ml) with Clonidine 30mcgs(0.3ml) intrathecally.

Group C - 40 patients will receive 5mg 0.5%(H) bupivacaine(1ml) with 0.3ml normal salineintrathecally.

Total volume of drug for all the groups will be 1.3ml.

 

Patients will be seated at the operating bed and the skin will be prepared with a povidone-iodine solution. Spinal anesthesia will be performed at either the L3-L4 or L4-L5 interspace through a midline approach using a 25-gauge Quincke needle. After verification that the cerebrospinal fluid is freely flowing from the hub, the hole of the spinal needle will be pointed downwards, and then agents will be injected for about 10 seconds following gentle aspiration. After the injection, the patients will be seated for 10 minutes and will then moved to a lithotomy position.

 

An anesthesiologist will record the anesthetic data and vital signs. Levels of sensory and motor blocks will be checked immediately before the lithotomy position. The sensory level will beexamined by cold perception using alcohol-soaked gauze and the motor block level by a modified Bromage scale (0, no motor block; 1, can flex knee, move foot, but cannot raise leg; 2, can move foot only; 3, cannot move foot or knee). Adverse effects due to spinal anesthesia such as hypotension, bradycardia, nausea, vomiting, and pruritus will be recorded during surgery, at the post-anesthesia care unit, and in the general wards.

 

The numeric rating scale (NRS) pain score and adverse effects will be checked postoperatively every 2 hours for the first 12 hours and then every 4 hours for next 36 hours. The NRS pain score ranging from 0 (no pain) to 10 (the most severe pain that the patient had ever experienced) and the primary outcome variable will be the NRS score at six hours postoperatively. We will be defining a patient to be experiencing rebound pain if the patient previously does not have any pain or NRS <4 and reports acute pain or  NRS >7 within 1 hour. Secondary outcome variables will include NRS changes between one and 48 hours postoperatively, rescue analgesic consumption, and the frequency of rebound pain. Patients will not be given any rescue analgesics till they have any pain. Rescue analgesics will be given if the patient complains of pain or has NRS pain score more than 4. The first rescue analgesic to be administered will be paracetamol (15mg/kg I.V) and second rescue analgesic will be tramadol (1mg/kg I.V). The total consumption of rescue analgesics will be counted upto 48 hours postoperatively. An NRS elevation after reaching the maximal NRS score between one and 48 hours post-surgically during a decrease in pain is defined as rebound pain.

 
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