Assessment of post operative pain after Total Lparoscopic Hysterectomy

Not yet recruiting

• Conditions: Other specified conditions associated with female genital organs and menstrual cycle,

• Registration Number: CTRI/2020/05/024994
• Lead Sponsor: Department of Obstetrics and Gynaecology

Brief Summary

All patients for totallaparoscopic hysterectomy( TLH )  forbenign condition will be recruited from gynaecology OPD at All India Instituteof Medical Sciences, New Delhi.

**Study Design****:** Prospective two armsdouble blinded Randomized Control Trial.

Total number ofpatients recruited will be– 60

Patients will berandomly allocated in two groups.

**Group I –** Intervention group (no. 30) that will receive Bupivacaineinfiltration to vaginal vault after TLH.

**Group II –** Control group (No. 30) that will not receive Bupivacaine infiltrationin vaginal vault.

The randomization ofparticipants into their respective group will be allocated using acomputer-generated randomization programme. The allocation cards will be sealedin sequentially numbered envelope. The principal surgeon will open theenvelopes in the operation theatre prior to surgery.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-05
• Study Start: 2020-04-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1.All patients who needs TLH with or without bilateral salpingo-oophorectomy for benign conditions.
• 2.Uterine size ≤12weeks of pregnancy.

Exclusion Criteria

1.Presence of malignancy 2.Contraindication to any medication which will be used in the study (Bupivacaine, paracetamol) 3.History of chronic PID 4.History of previous multiple surgeries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of post operative pain and short term morbidity in both the groups.	on post operative day 0. | 3hours, 6hours, 8 hours 12 and 24 hours

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES; 🇮🇳 Delhi, DELHI, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

🇮🇳Delhi, DELHI, India

Kanikaram Poojitha Kalyani

Principal investigator

9717468813

kpooji@gmail.com