Condition category
Pregnancy and Childbirth
Date applied
07/06/2006
Date assigned
05/07/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jens Engbaek

ORCID ID

Contact details

Department of Day Surgery
Copenhagen University Hospital at Herlev
Ringvej 75
Herlev
2730
Denmark

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

Sponsor information

Organisation

Glostrup University Hospital (Denmark)

Sponsor details

c/o Jørgen B Dahl
Glostrup University Hospital
Department of Anesthesiology
Nordre Ringvej 29-67
Glostrup
2600
Denmark

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes