NCT01184794

Brief Summary

This study is a blinded randomised study of slow release levobupivacaine vs saline for women undergoing day case operative pelvic laparoscopy. Participants will be randomly given either saline or levobupivacaine and efficacy will be measured using ranked ordinal pain scales and rescue oral analgesia use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

June 18, 2010

Last Update Submit

November 12, 2013

Conditions

Post Operative Analgesia

Keywords

Analgesia laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Rescue analgesia use

    participants will record number of doses of oral analgesic tablets they required.

    48 hours

Secondary Outcomes (1)

  • Pain intensity on movement and rest

    48 hours

Study Arms (2)

Saline

PLACEBO COMPARATOR

Placebo solution

Drug: levobupivacaine

levobupivacaine, analgesia

EXPERIMENTAL

Active drug

Drug: levobupivacaine

Interventions

levobupivacaineDRUG

40 ml over 48 hours

Also known as: Chirocaine
Salinelevobupivacaine, analgesia

Eligibility Criteria

Age16 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing 'Day case' operative laparoscopic procedures.
  • These women are deemed suitable to return home on the day of surgery, both in terms of physical fitness and their home circumstances.

You may not qualify if:

  • Women having laparoscopic procedures for diagnostic purposes or minor operations such as sterilisation, will be excluded from the study.
  • These procedures are less likely to cause significant pain due to operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashford & St Peter's Hospitals NHS Trust

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jeremy T Wright, MD

    Ashford and St. Peter's Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2010

First Posted

August 19, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

GB(1)