Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Approved by the Regional Ethics Committee of Copenhagen County on 15/04/2002; reference number: KA 02028s
Study design
Randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Gabapentin, lornoxicam, remifentanil, propofol, morphine
Primary outcome measures
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 trial start date
01/09/2002
Overall trial end date
01/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Women presenting with laparoscopic sterilization that have also given their informed consent to participate, aged between 26 and 50 years old
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant 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
Recruitment start date
01/09/2002
Recruitment end date
01/11/2004
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Day Surgery
Herlev
2730
Denmark
Funders
Funder type
Hospital/treatment centre
Funder name
Copenhagen University Hospital at Herlev (Denmark)
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17083725
Publication citations
-
Results
Bartholdy J, Hilsted KL, Hjortsoe NC, Engbaek J, Dahl JB, Effect of Gabapentin on morphine demand and pain after laparoscopic sterilization using Filshie clips. A double blind randomized clinical trial., BMC Anesthesiol, 2006, 6, 12, doi: 10.1186/1471-2253-6-12.