Local Anaesthetic Infusion For Laparoscopic Hysterectomy

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: 0.9% Saline; Drug: Levobupivicaine

• Registration Number: NCT01291147
• Lead Sponsor: Ashford and St. Peter's Hospitals NHS Trust

Brief Summary

More hysterectomies are performed laparoscopically either as a total laparoscopic hysterectomy or as a laparoscopically assisted vaginal hysterectomy. The advantages of laparoscopic surgery include quicker hospital discharge, a shorter convalescence and cost effectiveness when compared to open procedures. Laparoscopic hysterectomies (both total and vaginally assisted) can lead to discomfort which may lead to a delay in discharge from hospital. Continuous infusions of local anaesthetic agents given post operatively to the site of operation have the been subject of trials for several operative procedures. To date however there have not been any properly controlled studies evaluating whether there are benefits of giving a local anaesthetic infusion for 48 hours into the pelvis following a total or vaginally assisted laparoscopic hysterectomy. The investigators therefore propose to investigate whether giving a local anaesthetic infusion in this fashion decreases the amount of rescue and patient controlled analgesia needed, and length of hospital stay. In order to do this the investigators wish to conduct a randomised placebo controlled double blind trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Primary Completion: 2012-02
• Study Completion: 2013-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy

Exclusion Criteria

Women undergoing surgery for cancer, or are known to be allergic to local anaesthetic agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% Saline	0.9% Saline	-
Levobupivicaine	Levobupivicaine	-

Primary Outcome Measures

Name	Time	Method
• Need for 'rescue' analgesia	48 hours

Secondary Outcome Measures

Name	Time	Method
• Pain intensity	48 hours
Side effects from rescue analgesia	48 hours
Amount of patient controlled analgesia needed	48 hours
Hospital length of stay	48 hours
Patient satisfaction with pain relief	48 hours

Trial Locations

Locations (1)

Ashford and St Peter's Hospitals NHS Foundation Trust; 🇬🇧 Chertsey, Surrey, United Kingdom