| CTRI Number |
CTRI/2018/10/015982 [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
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of local anesthetic drug bupivacaine injected at the site of instrument entry in the abdomen during laparoscopic sterilization in females |
|
Scientific Title of Study
|
To compare the efficacy of intra-peritoneal instillation along with local infiltration with Bupivacaine versus placebo for post-operative analgesia after laparoscopic tubal ligation |
| 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,3rd Floor Bharati Hospital, Associate Professor Room,Bharati Vidyapeeth [deemed to be University] medical College, Pune
Department of Obstetrics and Gynecology,3rd Floor Bharati Hospital, Associate Professor Room,Bharati Vidyapeeth [deemed to be University] medical College, 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, 3rd Floor, Associate Professor Room, Bharati Vidyapeeth [deemed to be University] medical College, Pune
Department of Obstetrics and Gynecology,3rd Floor Bharati Hospital, Associate Professor Room,Bharati Vidyapeeth [deemed to be University] medical College, Pune
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,3rd Floor Bharati Hospital, Associate Professor Room,Bharati Vidyapeeth [deemed to be University] medical College, Pune
Department of Obstetrics and Gynecology,3rd Floor Bharati Hospital, Associate Professor Room,Bharati Vidyapeeth [deemed to be University] medical College, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
02045555555 |
| Fax |
|
| Email |
aniket1kakade@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aniket Kakade |
| Address |
Bharati Vidyapeeth [deemed to be University] Medical College, Pune |
| 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 and Gynecology,3rd Floor Bharati Hospital, Associate Professor Room,Bharati Vidyapeeth [deemed to be University] medical College, Pune
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 |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
Dose of Bupivacaine: 0.25mg/Kg
Concentration used: 0.25%.
Frequency: One time infiltration and instillation
Total Dosage: 20 ml of 0.25% bupivacaine to be instilled into the peritoneal cavity through the abdominal port. 5 ml of 0.25% bupivacaine to be infiltrated in the subcutaneous tissue at the sites of two ports: One Primary Umbilical Post and One secondary lateral port. |
| Comparator Agent |
Placebo: Normal Saline |
Dose of Bupivacaine: 30 ml.
Frequency: One time infiltration and instillation Total Dosage: 30 ml of Saline to be instilled into the peritoneal cavity through the abdominal port. 5 ml of Saline to be infiltrated in the subcutaneous tissue at the sites of two ports: One Primary Umbilical Post and One secondary lateral port. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all women who present for laparoscopic tubal ligation |
|
| ExclusionCriteria |
| Details |
any intra-operative complication like hematoma formation
avulsion of Fallopian tube
any allergy to used drug |
|
|
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. Pain to be assessed by visual analogue score [VAS] |
Time point: One hourly post operative for 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome Name: Side effects of drugs if any |
Time Points: every one hour for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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, comparing the efficacy of infiltration and instillation of local anesthetic drug bupivacaine versus placebo for post operative pain relief after laparoscopic tubal ligation. the drug bupivacaine will be used in dose of 0.25mg/kg of 0.25% solution. 10 ml will be infiltrated at the port site and 20 ml will be instilled intra peritoneal. control group will receive normal saline in same dose. Both group patients will be assessed by a blind assessor every hour by using the visual analogue score [VAS]. rescue analgesia will be administered at VAS 3 when patient complains of pain. any side effects of the drug will also be observed.
|