Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adam L Magos

ORCID ID

Contact details

University Department of Obstetrics and Gynaecology
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0256130924

Study information

Scientific title

Acronym

Study hypothesis

Does Adept prolong the action of local anaesthetic?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Post-operative pain

Intervention

Randomised controlled trial
Group 1: Bupivacaine + Saline (control)
Group 2: Bupivacaine + Adept

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Service outcome development

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/11/2003

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

35 patients in each group

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

04/11/2003

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Obstetrics and Gynaecology
London
NW3 2QG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Free Hampstead NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 feasibility study in http://www.ncbi.nlm.nih.gov/pubmed/15203590

Publication citations

  1. Feasibility study

    Buck L, Varras MN, Miskry T, Ruston J, Magos A, Intraperitoneal bupivacaine for the reduction of postoperative pain following operative laparoscopy: a pilot study and review of the literature., J Obstet Gynaecol, 2004, 24, 4, 448-451, doi: 10.1080/01443610410001685637.

Additional files

Editorial Notes