Pain Clinical Trial
Official title:
Gabapentin as an Adjunct for Pain Management During Dilation and Evacuation: A Double-blind Randomized Controlled Trial
Justification. Pain control is still an issue for women undergoing second trimester abortion
procedures. The investigators propose a randomized controlled double-blinded trial evaluating
the use of adjunct gabapentin versus placebo in addition to moderate sedation during D&E. The
investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the
time of cervical preparation initiation will improve intra-operative pain control. The
investigators also hypothesize that it will improve pre- and post-operative pain, anxiety,
nausea, vomiting, and overall satisfaction with pain management during D&E.
To test the hypotheses the investigators plan to enroll 130 participants who will be
randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of
cervical preparation.
Over 900,000 abortion procedures are performed annually in the United States [1]. For many
women, pain relief during abortion is inadequate despite the use of non-steroidal
anti-inflammatory drugs, local anesthetics, opioids, and/or moderate sedation. Research on
pain control during abortion has focused on methods for relief during first-trimester suction
curettage with little research dedicated to pain during dilation and evacuation (D&E).
Gabapentin (Neurontin) has emerged as an effective adjunct to pain management for a variety
of surgical procedures. Gabapentin is inexpensive and is also effective in reducing anxiety,
nausea, and vomiting. The addition of pre-operative gabapentin to moderate sedation during
D&E may lead to increased patient satisfaction and pain relief without significantly
increasing risk or cost.
Proposed Research. The investigators propose a randomized controlled double-blinded trial
evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation
during D&E. The investigators hypothesize that 600 mg oral gabapentin administered
pre-operatively at the time of cervical preparation initiation will improve intra-operative
pain control. The investigators also hypothesize that it will improve pre- and post-operative
pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D&E.
The investigators hypothesize that the doses of moderate sedation agents required to obtain
adequate sedation will be decreased if participants receive gabapentin, versus placebo. The
investigators also plan to compare the risk of adverse events with adjunct gabapentin versus
placebo with moderate sedation.
To test the hypotheses the investigators plan to enroll 130 participants who will be
randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of
cervical preparation. Baseline characteristics will be recorded. Pain will be assessed
pre-operatively, at 3 intraoperative time points, and postoperatively by 100 mm visual analog
scale (VAS). The investigators plan to assess satisfaction with pain control, nausea,
vomiting, and anxiety preoperatively and post-operatively, using 5-point Likert scales and
the State Trait Anxiety Inventory, respectively. A final assessment will be made by phone on
post-operative day one to evaluate overall satisfaction and perform a final screen for
adverse events.
New features. No publications have evaluated the use of gabapentin during abortion care,
although multiple studies are currently underway investigating gabapentin's effects during
first trimester abortion and during overnight cervical osmotic dilators. To the investigators
knowledge, this will be the first evaluation of gabapentin in conjunction with moderate
sedation for pain relief during same-day second trimester abortion.
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