| CTRI Number |
CTRI/2019/03/017929 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
01/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the safety and efficiency of low dose spinal anaesthesia in daycare female sterilization procedures |
|
Scientific Title of Study
|
Safety and efficacy of low dose intrathecal anaesthesia for outpatient 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 |
PRIYASMITA SARKAR |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Pain Medicine & Critical Care,
room no-5011,5th floor,Teaching Block,AIIMS,Ansari Nagar,
New Delhi-110029
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
priyasmitasarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Pain Medicine & Critical Care,
Room no.5011,5th floor,Teaching block,AIIMS, Ansari Nagar,
New Delhi-110029
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailendra Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Pain Medicine &Critical Care, AIIMSRoom no. 5011, 5th Floor,Teaching Block, Ansari Nagar, New Delhi -110029
Room no.5011,5th floor,Teaching block, Ansari Nagar,
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine & Critical care,room no.-5011, 5th floor, Teaching Block, Ansari Nagar,
New Delhi-110029 |
| Type of Sponsor |
Government 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 Shailendra Kumar |
ALL INDIA INSTITUTE OFMEDICAL SCIENCES |
Department of Anaesthesiology,Pain Medicine & Critical Care,
Room no.5011,5th floor,Teaching block, Ansari Nagar,
New Delhi-110029
South West
DELHI |
8745027472
drshail.kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fentanyl infusion with local anaesthetic infiltration at the port site |
i.v. fentanyl bolus 1microgram/kg followed by infusion @ 0.5microgram/kg/hr along with 10ml of 0.5% bupivacaine infiltration at the port site before trocar insertion |
| Intervention |
low dose spinal with i.v. fentanyl infusion |
low dose spinal with 3mg bupivacaine and 20microgram fentanyl diluted upto 2ml with NS with i.v. fentanyl bolus of 1microgram/kg followed by fentanyl infusion of 0.5microgram/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ASA I and II
SURGERY- ELECTIVE LAPAROSCOPIC TUBAL LIGATION |
|
| ExclusionCriteria |
| Details |
patient refusal
any contraindication to spinal anaesthesia
allergy to any of the study drugs
BMI>35
ASA III and IV
h/o any chronic abdominopelvic painful conditions
patients already on longterm opioids or non opioid analgesics
inability to comprehend VAS pain assessment scale |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
OVERALL PATIENT COMFORT DURING THE PROCEDURE
PATIENT VAS RATING DURING THE PROCEDURE |
OVERALL PATIENT COMFORT DURING THE PROCEDURE & OVERALL
PATIENT VAS RATING DURING THE PROCEDURE BOTH TO BE ASSESSED AT THE END OF THE PROCEDURE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
impact on discharge criteria-
-time to oral intake
-time to void
-time to ambulate
incidence of adverse events |
after the procedure every half hourly for 4 hours and over phone thrice on the next day and twice the day after. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2019 |
| 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
|
Nowadays laparoscopic tubal ligation is increasingly performed in outpatient setting due to reduced health care costs, early recovery and remarkable safety profle. However since the days of its introduction there have been attempts to develop asafe and effecive anaesthetic technique that facilitates early ambulation of these patients. General anaesthesia has been recommended but it is not a very safe technique. Spinal anaesthesia in standard doses is a good alternative but post spinal complications like prolonged motor blockade,urinary retention causes unacceptable delays in home dischargeto. Hence to overcome these challenges selective spinal anaesthesia with low dose bupivacaine has been considered here.Therefore we have decided to conduct this study to prove our hypothesis that selective spinal anesthesia with 3mg bupivacaine with 20 microgram fentanyl can provide excellent operating conditions with early ambulation,reduced duration f stay in PACU,better post operative analgesia less side effects and better overall patient satisfaction when compared with i.v. sedation wih fentanylwith periportal local anaesthetic infiltration in outpatient laparoscopic tubal ligation. |