A study to see the effect of local anaesthetic drug to decrease the pain after laparoscopic removal of uterus.

Completed

• Conditions: Excessive bleeding in the premenopausal period, (2) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified,

• Registration Number: CTRI/2021/10/037459
• Lead Sponsor: AIIMS Jodhpur

Brief Summary

Our trial found outsignificant reduction in pain scores after administration of paracervical blockfor preemptive analgesia.

The postoperative pain scores weresignificantly lower in the bupivacaine group; VAS at 30 minutes (5.804±1.301vs. 6.361±1.321, p=0.011); VAS at 60 minutes (6.112±1.268 vs. 6.609±1.272,p=0.019). The time to first mobilization was similar in both the groups (16.77±3.152vs. 17.26±3.504, p=0.376). The need for additional analgesia was reduced in thegroup receiving paracervical block with bupivacaine but the difference was notstatistically significant (24.3% vs. 28.4%, p=0.576). The duration of hospitalstay was similar in both groups (Interquartile range of 2-3 for both thegroups, p=0.23).

While the study did not find statistically significantdifferences in the surrogate markers of postoperative pain such asthe need for additional analgesia or duration of hospital stay, the trendtoward reduced analgesic requirements in the bupivacaine group is promising.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Study Completion: 2023-03-31
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Patients undergoing Laparoscopic Hysterectomy for benign conditions and for premalignant lesions requiring simple TLH without additional procedures ( like lymphnode dissection) 2.
• Patients consenting for the study.

Exclusion Criteria

• TLH for Extensive Endometriosis.
• TLH with Pelvic lymph nodal dissection in cases of Carcinoma Cervix, Carcinoma Endometrium.
• Uterus of size 14 weeks or higher.
• Allergy to Bupivacaine.
• Patients not giving consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in the VAS Score at 30 minutes and at 60 minutes after TLH in the subjects that received 0.5% Bupivacaine v/s those who	30 minutes and at 60 minutes
received Placebo.	30 minutes and at 60 minutes

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	48 hours

Trial Locations

Locations (1)

AIIMS Jodhpur Department of Obstetrics and Gynecology; 🇮🇳 Jodhpur, RAJASTHAN, India

AIIMS Jodhpur Department of Obstetrics and Gynecology

🇮🇳Jodhpur, RAJASTHAN, India

Dr Sumanjot Kaur

Principal investigator

8146675980

sumanjot83@gmail.com