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CTRI Number  CTRI/2024/06/068792 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 12/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   An observational study to evaluate the onset of effect of spinal anesthesia with addition of the drug Buprenorphine in the drug Ropivacaine 0.75% in lower abdominal surgeries and to study the duration of its effect during and after surgery 
Scientific Title of Study   AN OBSERVATIONAL STUDY TO EVALUATE ONSET OF SENSORY AND MOTOR BLOCKADE AND DURATION OF SENSORY AND MOTOR BLOCKADE WITH HYPERBARIC ROPIVACAINE(0.75%) WITH BUPRENORPHINE AS AN ADJUVANTS FOR LOWER ABDOMINAL SURGERIES UNDER SPINAL ANAESTHESIA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaibhavi Hajariwala 
Designation  Professor 
Affiliation  Shree Krishna Hospital, Pramukh Swami Medical College 
Address  Department of Anaesthesiology Shree Krishna Hospital, Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand

Anand
GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vaibhavi Hajariwala 
Designation  Professor 
Affiliation  Shree Krishna Hospital, Pramukh Swami Medical College 
Address  Department of Anaesthesiology Shree Krishna Hospital, Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand


GUJARAT
388325
India 
Phone  9909977446  
Fax    
Email  vaibhavih@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Akshita Patel 
Designation  Resident Doctor 
Affiliation  Shree Krishna Hospital, Pramukh Swami Medical College 
Address  Department of Anaesthesiology Shree Krishna Hospital, Pramukh Swami Medical College Gokal Nagar Karamsad, Dist. Anand

Anand
GUJARAT
388325
India 
Phone  8200002140  
Fax    
Email  akshita.ap.patel@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Shree Krishna Hospital, Gokal Nagar, Karamsad, Dist. Anand, Gujarat, India 388325 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Shree Krishna Hospital, Pramukh Swami Medical College, Gokal Nagar, Karamsad, Dist. Anand 
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 Akshita Patel  Shree Krishna Hospital, karamsad  ROOM NO 112 , Department of Anaesthesiology ,Shree Krishna Hospital, Pramukh Swami Medical College, Gokal Nagar, Karamsad, Dist. Anand
Anand
GUJARAT 
08200002140

akshita.ap.patel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2,bhaikaka university , karamsad, anand  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  Addition of Buprenorphine in Hyperbaric Ropivacaine 0.75% in spinal anesthesia for lower abdominal surgeries  23 G Quincke’s spinal needle will be inserted. After confirmation of needle tip in the subarachnoid space by free flow of cerebrospinal fluid, spinal anaesthesia will be given with hyperbaric ropivacaine (0.75%) 3 ML with buprenorphine 150mcg in L2-L3/L3-L4 space through a midline/paramedian approach 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with physical status of ASA(American society of Anaesthesiologists) ASA I to ASA III, Patients undergoing above mentioned lower abdominal surgeries
 
 
ExclusionCriteria 
Details  Patients refusal to spinal anaesthesia, Infection at site of spinal needle insertion, Patients having allergy to local anesthetic drug or drug used in the study, Coagulopathy or bleeding disorder, Increased intracranial pressure, Patients having instrumentation at the site of spinal needle insertion
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the sensory and motor onset and duration of sensory and motor blockade of hyperbaric ropivacaine with buprenorphine in lower abdominal surgeries under spinal anaesthesia  0 minutes, 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To observe post operative time of rescue analgesia, time of first micturition and time of mobilisation after hyperbaric Ropivacaine with Buprenorphine in lower abdominal surgeries under spinal anaesthesia   From the time of completion of surgery till 24 hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 1 
Date of First Enrollment (India)   24/06/2024 
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 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  

       After obtaining ethical committee approval and obtaining written and informed consent, patients   of ASA I to ASA III  who are undergoing elective lower abdominal surgeries such as abdominal hysterectomy, vaginal hysterectomy, open inguinal hernia repair ,open appendisectomy ,TURP etc. under spinal anaesthesia will be recruited to participate in this observational study.

             Pre anesthetic check up will be done in all patients with detailed history, general and systemic examination and investigations. After checking the adequate hours of nil by mouth, arrival to the pre-operative room heart rate, respiratory rate, blood pressure and spo2 will be recorded in all patients, an intravenous line will be checked and patients will be preloaded with iv fluids half an hour before anaesthesia.

             The patients will be placed in sitting/lateral  position, under all aseptic precautions skin and subcutaneous tissue will be infiltered with 2ml of 2% lignocaine. 23 G Quincke’s spinal needle will be inserted. After confirmation of needle tip in the subarachnoid space by free flow of cerebrospinal fluid, spinal anaesthesia will be given with  hyperbaric ropivacaine (0.75%) 3 ML with buprenorphine  150mcg  in L2-L3/L3-L4 space through a midline/paramedian approach. Our goal will to achieve the level of block at T8 level. After injection, patients will be placed in supine position immediately. Sensory effect will be assessed by pin prick method and motor effect will be assessed by modified bromage scale (grade 0- no loss of motor power to grade 4- complete paralysis).

              Using a preformed structured proforma the following parameters will be recorded: onset of sensory blockade, onset of motor blockade (Bromage scale 1), maximum dermatomal level of sensory blockade attained and the time to achieve it, maximum grade of motor blockade attained and the time to achieve it, total duration of analgesia and the duration of motor blockade (regression to bromage 0). Other parameters such as total duration of surgery, total intraoperative fluid given, hemodynamic monitoring till the full recovery of sensory and motor blockade will be noted. Patients will be also monitored for any adverse effects like bradycardia, hypotension, nausea, vomiting, headache, pruritus, urinary retention and any hypersensitivity reactions to drug.[4]

              In Post anaesthesia care unit, patients will be monitored for 30 minutes and then transferred to ward. Iv fluid for 6 hours will be given.  Post operative pain will be recorded at 6,12 and 24 hours after surgery using visual analogue score

 
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