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Completed

NCT Number: NCT00573963

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

2 injections of 20mL 0.375% ropivacaine - one given on each side.

Other names: Naropin

Saline Solution

Drug

2 injections of 20mL plain saline solution - one on each side.

Primary outcomes

  1. Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.

    Time frame: 24 hours

Secondary outcomes

  1. Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively.

    Time frame: 48 hours

  2. Opioid consumption at 6, 12, 24 & 48 hours postoperatively.

    Time frame: 48 hours

  3. Time to first maternal request for supplemental analgesia.

    Time frame: 48 hours

  4. Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively.

    Time frame: 48 hours

  5. Presence of pain 6 weeks postoperatively.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Determination of the Efficay of the Transversus Abdominis Plane (TAP) Block as Part of a Multimodal Regimen for Post-cesarean Delivery Analgesia: a Double Blinded Placebo-controlled Study.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 14, 2007
Registry last updated
Jul 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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