The Effectiveness of Gabapentin for Post-operative Pain Following Cesarean Section
Information source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: lactose (Drug); Gabapentin 300mg (Drug); Gabapentin 600mg (Drug)
Phase: N/A
Status: Completed
Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Official(s) and/or principal investigator(s): Jose CA Carvalho, MD, Principal Investigator, Affiliation: Mount Sinai Hospital, New York
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively
Secondary outcome: Pain at rest and on movement by VAS, and maternal satisfaction at 6, 12, 24 & 48 hours postoperativelyOpioid consumption at 6, 12, 24 & 48 hours postoperatively Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required Time to first maternal request for supplemental analgesia Presence of pain 3 months postoperatively Neonatal information: Apgar scores, arterial cord blood gases, need for neonatal intensive care unit (NICU) admission
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Mount Sinai Hospital, Toronto, Ontario M9W2S5, Canada
Additional Information
Starting date: April 2010
Last updated: February 22, 2011
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