| CTRI Number |
CTRI/2018/10/015979 [Registered on: 10/10/2018] Trial Registered Prospectively |
| Last Modified On: |
09/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the pain relief effect of two local anesthetic drugs ropivacaine and bupivacaine given to block the nerves located in abdominal wall after caesarean section. |
|
Scientific Title of Study
|
To Compare the efficacy of Ropivacaine versus Bupivacaine during Surgical transversus Abdominis plane block for post-operative analgesia after Caesarean Section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aniket Kakade |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth [Deemed to be University] Medical College, Pune |
| Address |
Department of Obstetrics and Gynecology, Bharati Vidyapeeth [deemed to be University] Medical College, Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
02045555555 |
| Fax |
|
| Email |
aniket1kakade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aniket Kakade |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth [Deemed to be University] Medical College, Pune |
| Address |
Department of Obstetrics and Gynecology, Bharati Vidyapeeth [deemed to be University] Medical College, Dhankawadi, Pune
MAHARASHTRA
411043
India |
| Phone |
02045555555 |
| Fax |
|
| Email |
aniket1kakade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniket Kakade |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth [Deemed to be University] Medical College, Pune |
| Address |
Department of Obstetrics and Gynecology, Bharati Vidyapeeth [deemed to be University] Medical College, Dhankawadi, Pune
MAHARASHTRA
411043
India |
| Phone |
02045555555 |
| Fax |
|
| Email |
aniket1kakade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth [Deemed to be University] Medical College, Bharati Hospital and Research Center, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Aniket Kakade |
| Address |
Department of Obs & Gyn,
3rd Floor,
Bharati Hospital,
Bharati Vidyapeeth [Deemed to be University] Medical College, Dhankawadi, Pune 411043. |
| Type of Sponsor |
Other [Investigator Initiated Trial] |
|
|
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 Aniket Kakade |
Bharati Hospital & Research Center |
Department of Obstetrics & Gynecology,
3rd Floor,
Room of Associate Professor,
Bharati Hospital,
Dhankawadi
Pune
MAHARASHTRA |
9850988568
aniket1kakade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati VIdyapeeth [Deemed to be University] Medical College Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Bupivacaine will be used to administer Surgical Transversus Abdominis plane block. Dose is 0.25ml/kg of 0.25% Bupivacaine. |
| Intervention |
Ropivacaine |
Ropivacaine will be used to administer the surgical transversus abdominis plane block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all patients who require caesarean delivery |
|
| ExclusionCriteria |
| Details |
Patient with ASA III or above
Any allergy to used drug
Local infection at the site of block
Patients requiring vertical abdominal incision and upper segment caesarean section
Patients requiring general anesthesia
Height of patient less than 150 cms and more than 180 cms (as these patients will require a different dosage of spinal anaesthesia)
Patients with thrombocytopenia.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: Post operative pain relief. To be assessed by Visual Analogue score [VAS] |
Time Point: One hourly assessment for 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: Side effects of the drugs |
Time Points: Every hour assessment in post operative period for 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, double blind, parallel group trial to compare the efficacy of ropivacaine versus bupivacaine during surgical transversus abdominis plane [TAP]block for post-operative analgesia after caesarean section. Surgical TAP block is a established technique used for post operative analgesia. we plan to compare two drugs in 100 patients who require caesarean section. The post operative pain will be assessed by using the visual analogue scale [VAS] and the duration of analgesia in hours after giving the drug by TAP block will be assessed. Rescue analgesia will be administered to all those patients who complain of pain at VAS 3. The secondary outcome will be study of any side effects of the drugs.
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