A study to see the safety and efficiency of low dose spinal anaesthesia in daycare female sterilization procedures

Not yet recruiting

• Conditions: Obstetrics,

• Registration Number: CTRI/2019/03/017929
• Lead Sponsor: All India Institute of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-03
• Study Start: 2019-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

ASA I and II SURGERY- ELECTIVE LAPAROSCOPIC TUBAL LIGATION.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OVERALL PATIENT COMFORT 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
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 Measures

Name	Time	Method
impact on discharge criteria-	-time to oral intake

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OFMEDICAL SCIENCES; 🇮🇳 West, DELHI, India

ALL INDIA INSTITUTE OFMEDICAL SCIENCES

🇮🇳West, DELHI, India

Dr Shailendra Kumar

Principal investigator

8745027472

drshail.kumar@gmail.com