Local Anaesthetic Infusion For Laparoscopic Hysterectomy

Postoperative Pain Clinical Trial

Official title:

Local Anaesthetic Infusion For Laparoscopic Hysterectomy: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291147
• Other study ID #: 2010JTW01
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2011
• Last updated: November 12, 2013
• Start date: February 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: Ashford and St. Peter's Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Levobupivicaine
levobupivicaine 0.5% continous infusion for 48 hours
• 0.9% Saline
0.9% saline continous infusion for 48 hours

Locations

Country	Name	City	State
United Kingdom	Ashford and St Peter's Hospitals NHS Foundation Trust	Chertsey	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Ashford and St. Peter's Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Need for 'rescue' analgesia		48 hours	No
Secondary	• Pain intensity		48 hours	No
Secondary	Side effects from rescue analgesia		48 hours	No
Secondary	Amount of patient controlled analgesia needed		48 hours	No
Secondary	Hospital length of stay		48 hours	No
Secondary	Patient satisfaction with pain relief		48 hours	No