Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery?
Condition: Pain
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 cesarean section. However, 19% of patients complained of sedation. A
      subsequent study at the same institution looked to see if lowering the dose to 300mg would
      decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The
      results were inconclusive but it provided valuable information to guide the design of this
      study.

      The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a
      48 hour low-dose course will produce improvement in pain scores. This study will compare the
      efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and
      200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women
      undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin
      will result in decreased pain scores and increased satisfaction.
    

Detailed description: 
      Postoperative pain can have a significant negative impact on the physical and psychological
      health of both mother and child after cesarean delivery. Furthermore, severe postoperative
      pain may lead to persistent pain for many months. Therefore, optimal prevention and treatment
      of post cesarean pain is of paramount importance in women's health.

      The current analgesic regimen most commonly used to manage pain after cesarean delivery
      includes neuraxial opioids, systemic acetaminophen and nonsteroidal anti-inflammatories, and
      systemic opioids for breakthrough pain. Although much improvement has been made with this
      regimen, pain scores assessment at 24 and 48 hours post cesarean delivery still show moderate
      pain, so further strategies to improve pain management are warranted.

      Gabapentin has been shown to reduce pain scores and opioid consumption in the post-operative
      period in a variety of surgical settings such as hysterectomy and mastectomy. Studies have
      also shown a benefit in continuing the drug as a peri-operative course.

      The use of gabapentin in cesarean deliveries is limited to 2 studies. The first trial at
      Mount Sinai Hospital found that a single dose of 600mg of gabapentin, administered
      preoperatively, significantly reduced the pain and increased the level of satisfaction of
      mothers who had delivered by cesarean section. There was however an increase in levels of
      sedation seen in those who received gabapentin and so a subsequent study was designed to see
      whether a reduced dose of 300mg could replicate the benefits shown without making mothers as
      drowsy. Unfortunately this study did not allow definitive conclusions to be drawn from the
      results as regards analgesic benefit, however the investigators did not observe an increase
      in sedation in patients receiving either 300 mg or 600 mg of gabapentin. Further studies are
      warranted to better define the role of gabapentin in this patient population.

      The purpose of this study is to evaluate the efficacy of a preoperative dose of gabapentin
      followed by a short course of gabapentin in the first 48 hours post cesarean delivery, in the
      context of a multimodal analgesic regimen inclusive of intrathecal morphine and systemic
      NSAIDs, acetaminophen and opioids.

      We hypothesize that this regimen will decrease VAS pains scores and increase maternal
      satisfaction post cesarean delivery.
    

Intervention name(s): Gabapentin; lactose
Intervention type(s): Drug; Drug
Other intervention name(s): 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: Gabapentin; Cesarean section