ISRCTN ISRCTN86456561
DOI https://doi.org/10.1186/ISRCTN86456561
Protocol serial number N0256130924
Sponsor Department of Health
Funder The Royal Free Hampstead NHS Trust (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
10/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Adam L Magos
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleIntraperitoneal bupivacaine for post-operative analgesia
Study objectivesDoes Adept prolong the action of local anaesthetic?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Post-operative pain
InterventionRandomised controlled trial
Group 1: Bupivacaine + Saline (control)
Group 2: Bupivacaine + Adept
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Bupivacaine
Primary outcome measure(s)

Service outcome development

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration70
Key inclusion criteria35 patients in each group
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment04/11/2003
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications feasibility study 01/06/2004 Yes No

Editorial Notes

10/11/2022: Proactive update review. No publications found. Search options exhausted.
22/11/2019: No publications found, verifying study status with principal investigator.