The Effectiveness of Gabapentin for Post-operative Pain Following Cesarean Section
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): lactose; Gabapentin 300mg; Gabapentin 600mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose; Single oral dose of 300mg gabapentin; Single oral dose of 600mg gabapentin
Other intervention name(s): Novo-gabapentin; Neurontin; Novo-gabapentin; Neurontin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean section; Gabapentin