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
|
|
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
|
|
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. |