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Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia

S

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Completed

Conditions

Pain

Treatments

Drug: saline solution
Drug: ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT00573963
07-0245-A
07-11

Details and patient eligibility

About

The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.

Full description

A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive an injection of local anesthetic on either side of their abdomen, into the plane of the transversus abdominis muscle. We are also interested in whether or not this injection decreases the need for other pain-killing medication during this time.

Patients will randomly be assigned to receive either local anesthetic or a placebo. In addition, all patients will receive the usual standard of care and medication for pain. At 6, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The risk of side effects is very low, as the block is done in an area with low blood supply. We propose that the addition of the TAP block to the current multi-modal regimen of post-cesarean pain management will reduce pain scores and requests for additional analgesia post-operatively, as well as increase patient satisfaction with their pain control.

Enrollment

100 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Women undergoing elective cesarean delivery

Exclusion criteria

  • Patients unable to communicate in English
  • Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
  • Patients with contraindications to spinal anesthesia
  • Patients with an allergy to ropivacaine, morphine, ketorolac or acetaminophen
  • Patients who have taken any pain medication in the past 24 hours
  • Patients with a BMI > 40

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Ropivacaine
Treatment:
Drug: ropivacaine
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: saline solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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