Local Anaesthetic Infusion For Laparoscopic Hysterectomy

NCT01291147 | Completed Phase 4

• 1 other identifier: 2010JTW01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

pain; anaesthetic

Outcome Measures

Primary Outcomes (1)

• • Need for 'rescue' analgesia

  48 hours

Secondary Outcomes (5)

• • 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

Study Arms (2)

Levobupivicaine

ACTIVE COMPARATOR

Drug: Levobupivicaine

0.9% Saline

PLACEBO COMPARATOR

Drug: 0.9% Saline

Interventions

Levobupivicaine DRUG

levobupivicaine 0.5% continous infusion for 48 hours

Levobupivicaine

0.9% Saline DRUG

0.9% saline continous infusion for 48 hours

0.9% Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women undergoing a total laparoscopic or laparoscopically assisted vaginal hysterectomy

You may not qualify if:

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

Sponsors & Collaborators

• Ashford and St. Peter's Hospitals NHS Trust: lead

Study Sites (1)

Ashford and St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Related Publications (1)

• Andrews V, Wright JT, Zakaria F, Banerjee S, Ballard K. Continuous infusion of local anaesthetic following laparoscopic hysterectomy--a randomised controlled trial. BJOG. 2014 May;121(6):754-60; discussion 761. doi: 10.1111/1471-0528.12610. Epub 2014 Feb 19.

  PMID: 24548730 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jeremy T Wright, MD FRCOG

  Ashford and St Peter's Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 8, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

GB (1)