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The Effectiveness of Gabapentin for Post-operative Pain Following Cesarean Section

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ClinicalTrials.gov Identifier: NCT01094925
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE March 29, 2010
Last Update Posted Date February 23, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01094925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
  • Pain at rest and on movement by VAS, and maternal satisfaction at 6, 12, 24 & 48 hours postoperatively [ Time Frame: 48 hours ]
  • Opioid consumption at 6, 12, 24 & 48 hours postoperatively [ Time Frame: 48 hours ]
  • Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required [ Time Frame: 48 hours ]
  • Time to first maternal request for supplemental analgesia [ Time Frame: 48 hours ]
  • Presence of pain 3 months postoperatively [ Time Frame: 3 months ]
  • Neonatal information: Apgar scores, arterial cord blood gases, need for neonatal intensive care unit (NICU) admission [ Time Frame: 48 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • Pain at rest and on movement by VAS, and maternal satisfaction at 6, 12, 24 & 48 hours postoperatively [ Time Frame: 48 hours ]
  • Opioid consumption at 6, 12, 24 & 48 hours postoperatively [ Time Frame: 48 hours ]
  • Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required [ Time Frame: 48 hours ]
  • Time to first maternal request for supplemental analgesia [ Time Frame: 48 hours ]
  • Presence of pain 3 months postoperatively [ Time Frame: 3 months ]
  • Neonatal information: Apgar scores, arterial cord blood gases, need for NICU admission [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Gabapentin for Post-operative Pain Following Cesarean Section
Official Title  ICMJE The Effectiveness of a Pre-operative Single Dose Administration of Gabapentin for Management of Post-operative Pain Following Cesarean Section: a Randomised, Double-blind, Placebo-controlled, Dose-finding Study
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.
Detailed Description

Post-operative pain is the greatest fear of women who undergo Cesarean section, and despite current analgesic regimens, this pain can be severe, impeding the mother's recovery and her ability to bond with and breastfeed her new infant. Opioids are the mainstay of treatment currently, and, although effective, these drugs have significant adverse effects, including sedation, nausea, vomiting and constipation. Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce opioid consumption, but also have side effects, and are contra-indicated in a significant number of patients. Therefore there remains considerable scope to improve post-Cesarean analgesia.

It has been shown that severe acute post-operative pain after Cesarean section increases the risk of developing chronic pain and post-partum depression. A recent study showed that up to 18% of women have persistent pain after Cesarean section, and that severe acute post-operative pain is a significant risk factor.

Gabapentin is used widely to treat chronic pain, and has been demonstrated to be effective at treating acute post-operative pain following a variety of surgical procedures, with significant reductions in opioid consumption. Side effects are uncommon; the most likely are dizziness and sedation. Gabapentin does cross the placenta and into breast milk, but there is no evidence of adverse maternal or neonatal effects in women taking gabapentin during pregnancy. Gabapentin has been used successfully to treat pain in neonates.

A recent study at Mount Sinai Hospital compared a single pre-operative dose of 600mg gabapentin versus placebo in women undergoing Cesarean section. Women in the gabapentin group reported significantly improved pain scores on movement up to 48 hours after surgery. Side effects were similar in both groups apart from an increase in somnolence in the gabapentin group.

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. Our hypothesis is that gabapentin 300mg will result in decreased pain scores similar to gabapentin 600mg, but with reduced side effects. We have designed a randomized, double-blind, placebo-controlled study which will aim to answer these questions. Aside from the administration of gabapentin one hour prior to surgery, there are no other changes to the standard protocol of anaesthetic care. Women will be followed up for 48 hours after surgery for assessment of pain scores and overall satisfaction. A further follow-up at three months will determine the incidence of chronic pain.

Few studies have examined the incidence of chronic pain following Cesarean section, and none have examined the impact of pre-emptive analgesia using gabapentin on the incidence of chronic pain following Cesarean section. As the rate of Cesarean section continues to increase, and there remain significant problems with current analgesic regimens, the use of gabapentin, a drug with proven effectiveness in post-surgical pain and with limited side effects, has the potential to considerably improve acute and chronic post-Cesarean pain, and lead to a widespread change in clinical practice.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: lactose
    Single oral dose
  • Drug: Gabapentin 300mg
    Single oral dose of 300mg gabapentin
    Other Names:
    • Novo-gabapentin
    • Neurontin
  • Drug: Gabapentin 600mg
    Single oral dose of 600mg gabapentin
    Other Names:
    • Novo-gabapentin
    • Neurontin
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: lactose
  • Active Comparator: Gabapentin 300mg
    Intervention: Drug: Gabapentin 300mg
  • Active Comparator: Gabapentin 600mg
    Intervention: Drug: Gabapentin 600mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2010)
126
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094925
Other Study ID Numbers  ICMJE 10-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jose C.A. Carvalho, Mount Sinai Hospital
Study Sponsor  ICMJE Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL
PRS Account Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP