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CTRI Number  CTRI/2020/08/027221 [Registered on: 18/08/2020] Trial Registered Prospectively
Last Modified On: 17/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to evaluate effectiveness of drug tramadol for pain free period after gynecological surgeries 
Scientific Title of Study   Comparison of sensory blockade and duration of post operative analgesic effect between bupivacaine heavy and bupivacaine heavy plus tramadol intrathecally in patients undergoing gynecological surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhavi Chaudhari 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College Shree Krishna Hospital 
Address  Department of AnaesthesiologyPramukh Swami Medical College,Karamsad

Anand
GUJARAT
388325
India 
Phone  9427084963  
Fax    
Email  madhavic@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhumika Pathak 
Designation  Associate Professor, Department of Anaesthesiology 
Affiliation  Pramukh Swami Medical College Shree Krishna Hospital 
Address  Department of AnaesthesiologyPramukh Swami Medical College,Karamsad

Anand
GUJARAT
388325
India 
Phone  9904438877  
Fax    
Email  docbhum29@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Parth B Bhatt 
Designation  PG Student ,Department of Anaesthesiology 
Affiliation  Department of Anaesthesiology,Pramukh Swami Medical College 
Address  Department of Anaesthesiology,Pramukh Swami Medical College,Shree Krishna hospital,gokal nagar Karamsad,anand sojitra road
Shree Krishna hospital,gokal nagar Karamsad,anand sojitra road, 388325
Anand
GUJARAT
388325
India 
Phone  9998071635  
Fax    
Email  parth.bhatt259@gmail.com  
 
Source of Monetary or Material Support  
Pramukh Swami medical college, Shree Krishna Hospital, Gokalnagar, Karamsad, Anand-sojitra road, 388325 
 
Primary Sponsor  
Name  Shree krishna hospital 
Address  Anand sojitra road karamsad gujarat 
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 Madhavi Chaudhari  Pramukh Swami Medical College, Shree Krishna hospital, Karamsad  Department of Anesthesiology, Shree Krishna Hospital, Anand-sojitra road, Gokalnaar, Karamsasd 388325
Anand
GUJARAT 
9427084963

madhavic@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H.M Patel Center for medical care and education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Post operative analgesic effect of Bupivacaine heavy 3ml that is 15mg plus tramadol 0.5 ml that is 25mg INTRATHECALLY in spinal anaesthesia  Post operative analgesic effect of Bupivacaine heavy 3ml that is 15mg plus tramadol 0.5 ml that is 25mg INTRATHECALLY in spinal anaesthesia in patients undergoing gynecological surgeries.20 patients will be randomly distributed in each group. total 40 patients will be assessed in the study over the period of 18 months since approval 
Comparator Agent  Post operative analgesic effect of Bupivacaine heavy plus Normal Saline in spinal anaesthesia  comparison of sensory blockade and post operative analgesic effect of bupivaciane heavy only with normal saline and bupivacaine heavy plus tramadol intrathecally in spinal anesthesia in patients undergoing gynecological surgeries  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  ASA grade 1-3 physical status 
 
ExclusionCriteria 
Details  Hypersensitivity to local anesthetics, absolute contraindications to spinal anesthesia that is patients refusal, any bleeding diathesis patients, local site infection,relative contraindications like severe hypotension, obstructive cardiomyopathies, any spinal deformity, spinal cord injnury 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Parameter that will be used to evaluate effect of addition of tramadol in post-operative analgesic effect of drug is VISUAL ANALOG SCALE (VAS) SCORE. VAS score will be assessed every 40 minute interval till 6 hours post-operatively for the first analgesic requirement.  Parameter that will be used to evaluate effect of addition of tramadol in post-operative analgesic effect of drug is VISUAL ANALOG SCALE (VAS) SCORE. VAS score will be assessed every 40 minute interval till 6 hours post-operatively for the first analgesic requirement. 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic stability. PARAMETERS that will be assessed are HYPOTENSION, BRADYCARDIA, ARRYTHMIAS, DESATURATION and side effects like NAUSEA, VOMITTING, PRURITUS, SHIVERING and URINARY RETENTION in patients undergoing gynecological surgeries. THIS PARAMETERS WILL BE ASSESSED INTRA-OPERATIVELY THROUGHT THE SURGERY.  Hemodynamic stability. PARAMETERS that will be assessed are HYPOTENSION, BRADYCARDIA, ARRYTHMIAS, DESATURATION and side effects like NAUSEA, VOMITTING, PRURITUS, SHIVERING and URINARY RETENTION in patients undergoing gynecological surgeries. THIS PARAMETERS WILL BE ASSESSED INTRA-OPERATIVELY THROUGHT THE SURGERY. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/08/2020 
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  

Intrathecal opioid administration has been demonstrated to provide effective postoperative analgesia after a variety of surgical procedures, albeit at the cost of an increased risk for respiratory depression. Tramadol, in contrast, is a centrally acting analgesic that has minimal respiratory depressant effects, by virtue of its 6000-fold decreased affinity for mu receptors compared with morphine.  It also inhibits serotonin and norepinephrine reuptake in the spinal cord and has no reported neural toxicity. Accordingly, tramadol has the potential to provide effective postoperative analgesia with no risk of respiratory depression after central neuraxial administration. Although epidural tramadol has been demonstrated to provide adequate postoperative analgesia in patients undergoingmajor abdominal surgery and Caesarean section, its efficacy after intrathecal administration has not yet been studied well. Now a days various adjuvants are used in spinal anesthesia like dexmedetomadin and fentanyl to prolong the duration of sensory blockade and post op analgesia, but tramadol is far more cost effective than dexmedetomedin and other adjuvants. So, The study is undertaken to evaluate the duration of analgesia and/or pain free period produced by intra thecal tramadol added to bupivacaine heavy in pts undergoing any infra umbilical surgery.

 
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