Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0256130924
Study information
Scientific title
Intraperitoneal bupivacaine for post-operative analgesia
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
Drug
Phase
Not Applicable
Drug names
Bupivacaine
Primary outcome measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2004 feasibility study in http://www.ncbi.nlm.nih.gov/pubmed/15203590
Publication citations
-
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.