Effect of gabapentin on morphine demand and pain after laparoscopic sterilization using Filshie® clips. A double blind randomised clinical trial
| ISRCTN | ISRCTN39209275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39209275 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/06/2006
- Registration date
- 05/07/2006
- Last edited
- 25/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jens Engbaek
Scientific
Scientific
Department of Day Surgery
Copenhagen University Hospital at Herlev
Ringvej 75
Herlev
2730
Denmark
Study information
| Study design | Randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | A considerable number of patients require opioids during recovery after laparoscopic sterilization. This implies nausea, dizziness and sedation and this increases the number of unplanned admissions. Gabapentin has shown excellent postoperative analgesic effects in a number of recent studies showing few side effects. This study was designed to test whether gabapentin given preoperatively can reduce the number of patients needing morphine in the recovery period. |
| Ethics approval(s) | Approved by the Regional Ethics Committee of Copenhagen County on 15/04/2002; reference number: KA 02028s |
| Health condition(s) or problem(s) studied | Post operative pain after laparoscopic sterilization |
| Intervention | Females scheduled for laparoscopic sterilization using Filshie clips were randomised into two treatment groups (gaba group and control group). All patients received lornoxicam 8 mg by oral administration (p.o.) for 30 min before the procedure. Patients in the gaba group received gabapentin 1,200 mg p.o. and patients in the control group received placebo capsules prior to the procedure. All patients were anesthetized according to a protocol, using remifentanil and propofol. Postoperative analgesia was obtained with patient-controlled infusion of morphine. Pain, nausea, dizziness and sedation were scored at two and four hours after end of anesthesia. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gabapentin, lornoxicam, remifentanil, propofol, morphine |
| Primary outcome measure | The primary outcome measure was number of patients requesting morphine during the first four postoperative hours |
| Secondary outcome measures | 1. Total morphine consumption from 0-4 hours postoperatively 2. Pain at rest and during mobilization from the supine to the sitting position 2. Side effects: nausea, sedation, dizziness, and vomiting |
| Overall study start date | 01/09/2002 |
| Completion date | 01/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Key inclusion criteria | Women presenting with laparoscopic sterilization that have also given their informed consent to participate, aged between 26 and 50 years old |
| Key exclusion criteria | 1. Allergy toward gabapentin 2. Diabetes 3. Renal disease 4. Psychiatric disorder 5. Abuse of drugs 6. Analgesic treatment within 24 hours before the study 7. Treatment with steroids |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/11/2004 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Day Surgery
Herlev
2730
Denmark
2730
Denmark
Sponsor information
Glostrup University Hospital (Denmark)
University/education
University/education
c/o Jørgen B Dahl
Glostrup University Hospital
Department of Anesthesiology
Nordre Ringvej 29-67
Glostrup
2600
Denmark
"ROR" |
https://ror.org/05p1frt18 |
|---|
Funders
Funder type
Hospital/treatment centre
Copenhagen University Hospital at Herlev (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/11/2006 | Yes | No |
