Recruiting

TAP Catheters vs. Intrathecal Morphine

Sponsor:

Stamford Anesthesiology Services, PC

Code:

NCT01593280

Conditions

Abdominal Muscles/Ultrasonography

Adult

Anesthetics, Local/Administration & Dosage

Ropivacaine/Administration & Dosage

Ropivacaine/Analogs & Derivatives

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

TAP catheter

intrathecal morphine

Study Details

Brief summary:

Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and pruritus, which may affect quality of recovery. The investigators hypothesize that long-acting local anesthetic infusions via TAP catheter can provide better quality of recovery after cesarean section than spinal morphine.

Conditions

Abdominal Muscles/Ultrasonography

Adult

Anesthetics, Local/Administration & Dosage

Ropivacaine/Administration & Dosage

Ropivacaine/Analogs & Derivatives

Study ID

NCT01593280

Start date

May, 2012

Status verified date

May, 2012

Primary completion date

Feb, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients age 18 - 45 years of age undergoing cesarean section under spinal anesthesia.
  • Ability to read and write English

Exclusion Criteria:

  • Patients undergoing other concomitant procedure
  • Patients with history of diabetes or chronic steroid use
  • Patients with chronic or recent (within 1 week prior to procedure) opioid use.
  • Patients without the mental capacity to consent for the procedure/study.
  • Patients requiring a translator in order to sign the consent for the procedure/study.
  • Patients with a history of allergic reactions to local anesthetics

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TAP catheter

Indwelling TAP catheter placed at the end of c-section. It will be dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen OnQ C-block pump containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The catheters will run at 7cc/hr/side for 50 hrs.

active comparator: intrathecal morphine

0.3 mg of intrathecal morphine

Interventions

TAP catheter

dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen pump containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The time that this occurs will be recorded in the eMAR. The catheters will run at 7cc/hr/side for 50 hrs.

intrathecal morphine

0.3 mg

Primary outcome measure

  • Quality of recovery after cesarean section [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Vlad Frenk, MD

203 276-7490vfrenk@stmahealth.org

Locations

Stamford Hospital

Recruiting

Stamford, Connecticut, United States, 06904

Principal Investigator:

Vlad Frenk, MD

More Information

Sponsor

Stamford Anesthesiology Services, PC

Last update posted

May 8, 2012

Last verified

May, 2012

Keywords

  • anesthesia
  • regional anesthetic techniques: transversus abdominis plane block,
  • pain, postoperative
  • surgery, cesarean section
  • quality of recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stamford Anesthesiology Services, PC on 2012-05-08.