NCT01094925

Brief Summary

Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of operations. A previous study at the investigators' hospital found that a single pre-operative dose of 600mg gabapentin produced a significant reduction in pain after caesarean section. However, 19% complained of sedation. The purpose of this study is to see whether a reduced dose of gabapentin will produce a similar improvement in pain scores while avoiding adverse effects such as sedation or dizziness. The objective of this study is to compare the efficacy of a single pre-operative oral dose of gabapentin 300mg, versus 600mg and placebo in women undergoing Cesarean section. The investigators' hypothesis is that gabapentin 300mg will result in decreased pain scores similar to gabapentin 600mg, but with reduced side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

8 months

First QC Date

March 25, 2010

Last Update Submit

February 22, 2011

Conditions

Pain

Keywords

Cesarean sectionGabapentin

Outcome Measures

Primary Outcomes (1)

  • Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively

    24 hours

Secondary Outcomes (6)

  • Pain at rest and on movement by VAS, and maternal satisfaction at 6, 12, 24 & 48 hours postoperatively

    48 hours

  • Opioid consumption at 6, 12, 24 & 48 hours postoperatively

    48 hours

  • Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required

    48 hours

  • Time to first maternal request for supplemental analgesia

    48 hours

  • Presence of pain 3 months postoperatively

    3 months

  • +1 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: lactose

Gabapentin 300mg

ACTIVE COMPARATOR
Drug: Gabapentin 300mg

Gabapentin 600mg

ACTIVE COMPARATOR
Drug: Gabapentin 600mg

Interventions

lactoseDRUG

Single oral dose

Placebo
Gabapentin 300mgDRUG

Single oral dose of 300mg gabapentin

Also known as: Novo-gabapentin, Neurontin
Gabapentin 300mg
Gabapentin 600mgDRUG

Single oral dose of 600mg gabapentin

Also known as: Novo-gabapentin, Neurontin
Gabapentin 600mg

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years or older
  • full term singleton pregnancy
  • undergoing elective cesarean delivery

You may not qualify if:

  • Patients unable to communicate fluently in English
  • Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater
  • Patients with history of epilepsy or chronic pain, or of use of anti-epileptic drugs or neuropathic analgesic drugs
  • Patients with a history of opioid or intravenous drug abuse
  • Patients with a known allergy or contra-indication to gabapentin, or to any other drugs used in this trial
  • Patients who have refused spinal anaesthesia, or those in whom it is contra-indicated
  • Patients with known congenital fetal abnormalities
  • Patients who have taken antacid medication in the previous 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M9W2S5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

LactoseGabapentin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsAminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 29, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

CA(1)