Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kristopher Schroeder, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01411917
First received: August 4, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

Consenting subjects will be randomized to receive injection of bupivacaine or placebo before surgery for ileostomy takedown (injection administered after general anesthesia has been administered). Pain and side effects will be assessed periodically after surgery using the verbal Numeric Rating pain Scores, including at the timepoint of 24 hours after surgery. All subjects in this study will be given toradol to ensure adequate pain control.


Condition Intervention Phase
Ileostomy - Stoma
Procedure: Transversus abdominis plane block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 24 hour postoperative opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    We aim to evaluate whether patients consume less opioids, over the first 24 hours post-operatively following ileostomy takedown, with the addition of a pre-operative Transversus Abdominis Plane (TAP) block for analgesia.


Secondary Outcome Measures:
  • Pain scores at post-anesthesia care unit (PACU) admission and discharge [ Time Frame: Surgical PACU (Approximately 2 hours post-anesthesia) ] [ Designated as safety issue: No ]
  • Pain scores at 24 hours post-block [ Time Frame: 24 hours post-block ] [ Designated as safety issue: No ]
  • Time from PACU recovery room admission until meeting recovery room discharge criteria [ Time Frame: Approximately two hours post-anesthesia ] [ Designated as safety issue: No ]
  • Intra-operative opioid use [ Time Frame: Approximately 2-3 hours after block/placebo placement ] [ Designated as safety issue: No ]
  • PACU opioid use [ Time Frame: Approximately two hours post-anesthesia ] [ Designated as safety issue: No ]
  • Incidence of post-operative nausea [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Time to hospital discharge [ Time Frame: Typically less than one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP block group
Patients in this group will have a preoperative, ultrasound guided injection of 30ml of 0.375% bupivacaine into the muscle plane between the transversus abdominis muscle and internal oblique muscles.
Procedure: Transversus abdominis plane block
Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
Placebo Comparator: Placebo
Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.
Procedure: Transversus abdominis plane block
Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients having an ileostomy takedown alone, on one side of abdomen
  2. Ages 18-80 inclusive
  3. English speaking
  4. BMI less than 40
  5. Ability to understand verbal pain scale
  6. American Society of Anesthesiologists (ASA) Physical Status 1-3

Exclusion Criteria:

  1. Allergy to local anesthetics
  2. History of recent/current local or generalized infection
  3. Immunocompromised
  4. Significant psychiatric disease
  5. History of opioid dependence
  6. Pregnancy or lactation
  7. A prisoner.
  8. Significant liver disease
  9. Contraindication to ondansetron or dexamethasone
  10. Clinically significant cardiac or pulmonary disease
  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: NCT01411917

Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: Kristopher Schroeder, Assistant Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01411917     History of Changes
Other Study ID Numbers: 2011-0249
Study First Received: August 4, 2011
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
surgical stomas
Nerve block

ClinicalTrials.gov processed this record on October 23, 2014