Randomised, double-blind, placebo-controlled trial to identify any morphine-sparing effects of preoperative propacetamol in patients undergoing laparoscopic sterilisation by clip occlusion of fallopian tubes
| ISRCTN | ISRCTN30982801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30982801 |
| Protocol serial number | N0226107795 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
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 Neil Braude
Scientific
Scientific
Department of Anaesthesia
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 0161 291 2502 |
|---|---|
| Neil.Braude@smuht.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To demonstrate that preoperative administration of paracetamol (as intravenous propacetamol) in female patients undergoing laparoscopic sterilisation (by tubal clip occlusion) reduces postoperative morphine requirements. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | 1. Propacetamol 2. Placebo July 2008: trial stopped, drug no longer available and replaced by an alternative agent. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | propacetamol |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 40 |
| Key inclusion criteria | 20 patients undergoing female laparoscopic sterilisation as a day-case and 20 controls. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthesia
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
