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Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study

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ClinicalTrials.gov Identifier: NCT01411917
Recruitment Status : Terminated (Recruitment Difficulties due to some factors)
First Posted : August 8, 2011
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Ileostomy - Stoma Procedure: Transversus abdominis plane block

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study
Study Start Date : August 2011
Primary Completion Date : November 30, 2015
Study Completion Date : November 30, 2015
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 24 hour postoperative opioid consumption [ Time Frame: 24 hours ]
    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 :
  1. Pain scores at post-anesthesia care unit (PACU) admission and discharge [ Time Frame: Surgical PACU (Approximately 2 hours post-anesthesia) ]
  2. Pain scores at 24 hours post-block [ Time Frame: 24 hours post-block ]
  3. Time from PACU recovery room admission until meeting recovery room discharge criteria [ Time Frame: Approximately two hours post-anesthesia ]
  4. Intra-operative opioid use [ Time Frame: Approximately 2-3 hours after block/placebo placement ]
  5. PACU opioid use [ Time Frame: Approximately two hours post-anesthesia ]
  6. Incidence of post-operative nausea [ Time Frame: 24 hours ]
  7. Time to hospital discharge [ Time Frame: Typically less than one week ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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