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Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain

This study has been withdrawn prior to enrollment.
(PI was unable to locate appropriate population)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00945620
First received: July 22, 2009
Last updated: June 4, 2015
Last verified: June 2015
  Purpose

The primary aim of this study is to measure the magnitude and duration of trans-abdominis plane (TAP) block analgesia in parturients undergoing elective cesarean section with concurrent standard of care operative analgesic regimens including intrathecal morphine sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain created by a bilateral surgical wound and allows each patient to serve as her own control. Reduced variability allows a more definitive establishment of analgesic benefit for this block.

The current reports of conflicting data regarding efficacy make uncertain the role of TAP block in post cesarean section pain relief. This model would have a better potential for measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows for assessment of block regression over time. Pressure algometry has been established as a clinical and research tool for quantitative assessment of pain levels in multiple pain conditions. A useful inexpensive reliable pressure algometer has recently been described.

The assessment of serum ropivicaine levels with this block will provide useful data regarding the systemic absorption of local anesthetic compared to other peripheral nerve blocks and establish the safety of the technique.

In addition this study will help establish a model for the study of TAP block modifications in the future. If block effectiveness is demonstrated, this model can be used to examine numerous block parameters including choice of local anesthetic and dose response analysis for optimal volume and concentration. Potential future study may be done also in the area of adjuncts found to have increased duration and effectiveness as used in other peripheral nerve blocks.

Expected duration of this study is 18 months.


Condition Intervention
Pain Control
Drug: ropivicaine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain: A Randomized Double-Blinded Case Control Trial

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Difference in pain perception based upon VAS scores at rest between blocked and unblocked side in each subject [ Time Frame: 4, 6, 8, 12, 16, 20 and 24 hours post TAP placement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in pain perception [ Time Frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP ] [ Designated as safety issue: No ]
  • Duration of time at pain perception between sides is equal [ Time Frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP ] [ Designated as safety issue: No ]
  • Duration of time skin sensation of touch [ Time Frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP ] [ Designated as safety issue: No ]
  • Assessment of ropivacaine levels [ Time Frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: right side
The trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed
Drug: placebo
Placebo
Placebo Comparator: Left side
The trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed
Drug: ropivicaine
30mL containing 300mg ropivicaine 1% with addition of 1:300,000 epinepherine
Other Name: Trans-Abdominis Plane Block, ropivicaine, naropin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Pre-pregnancy body mass index less than or equal to 35
  • Elective repeat cesarean section under SAB or CSE (patients in whom the epidural catheter is activated intra-operatively will be excluded)
  • English-Speaking patient
  • Age at least 18 and no more than 40 years old.

Exclusion Criteria:

  • Chronic pain or daily consumption of pain medications
  • Neurologic disorders producing altered sensory perception or impaired motor strength in lower extremities or abdomen
  • Pre-existing epidural analgesia infusion for labor analgesia.
  • Spinal anesthetic failure requiring epidural catheter use or general anesthesia
  • Intra-operative conversion to general anesthesia for fetal indications.
  • Cesarean section performed with a vertical (not Phannenstiel) incision
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945620

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

Responsible Party: Sarah A. Starr, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00945620     History of Changes
Other Study ID Numbers: VUMC01TAP  TAP 
Study First Received: July 22, 2009
Last Updated: June 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Trans-abdominis block
post-cesarean

ClinicalTrials.gov processed this record on December 08, 2016