Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Status: | Completed |
---|---|
Conditions: | Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/14/2018 |
Start Date: | December 8, 2016 |
End Date: | June 26, 2018 |
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2
hours preoperatively in conjunction with perioperative paracervical block for surgical
abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce
perioperative and postoperative pain associated with surgical abortion. Additionally, the
researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and
consumption of pain medication.
hours preoperatively in conjunction with perioperative paracervical block for surgical
abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce
perioperative and postoperative pain associated with surgical abortion. Additionally, the
researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and
consumption of pain medication.
Project Summary
Justification for the project
One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending
in pregnancy termination by abortion. Elective abortions are among the most common outpatient
surgical procedure, with an estimated 46 million performed worldwide annually. The management
of pain is critical to patient care throughout the abortion experience since the vast
majority of women will experience pain with the procedure. Patients are most affected by pain
during paracervical block, cervical dilation, suction aspiration, and post operatively with
uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting
using a low cost, well-tolerated intervention could impact thousands of women each year.
Proposed research
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2
hours preoperatively in conjunction with perioperative paracervical block for surgical
abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce
perioperative and postoperative pain associated with surgical abortion. Additionally, the
researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and
consumption of pain medication.
New features
The use of gabapentin in the setting of abortion has never been evaluated. Its use in similar
surgical settings as an adjunct to pain management regiments has proven to be beneficial. It
is generally well tolerated, inexpensive, has minimal side effects, and few
contraindications.
Problems anticipated
The high volume at the study clinic will benefit recruitment efforts, however, as the
coordination of this study may potentially disrupt clinic flow there will be limits on daily
recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to
follow-up, most of the outcomes are measured on the same day as the procedure. Further,
multiple contact approaches will be employed and a second incentive offered after completion
of the postoperative assessment.
Justification for the project
One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending
in pregnancy termination by abortion. Elective abortions are among the most common outpatient
surgical procedure, with an estimated 46 million performed worldwide annually. The management
of pain is critical to patient care throughout the abortion experience since the vast
majority of women will experience pain with the procedure. Patients are most affected by pain
during paracervical block, cervical dilation, suction aspiration, and post operatively with
uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting
using a low cost, well-tolerated intervention could impact thousands of women each year.
Proposed research
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2
hours preoperatively in conjunction with perioperative paracervical block for surgical
abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce
perioperative and postoperative pain associated with surgical abortion. Additionally, the
researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and
consumption of pain medication.
New features
The use of gabapentin in the setting of abortion has never been evaluated. Its use in similar
surgical settings as an adjunct to pain management regiments has proven to be beneficial. It
is generally well tolerated, inexpensive, has minimal side effects, and few
contraindications.
Problems anticipated
The high volume at the study clinic will benefit recruitment efforts, however, as the
coordination of this study may potentially disrupt clinic flow there will be limits on daily
recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to
follow-up, most of the outcomes are measured on the same day as the procedure. Further,
multiple contact approaches will be employed and a second incentive offered after completion
of the postoperative assessment.
Inclusion Criteria:
- Women >=18 years-old
- Presenting for a surgical abortion
- Fluency in English and able to provide informed consent
- Has a driver to take them home following the procedure
Exclusion Criteria:
- Allergy, sensitivity or contraindication to gabapentin
- Severe renal disease
- Currently using gabapentin or pregabalin
- Contraindication to outpatient abortion under local anesthesia
We found this trial at
1
site
Atlanta, Georgia 30342
Principal Investigator: Lisa Haddad, MD, MS, MPH
Phone: 404-778-1385
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