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

History of Changes

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.

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Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Allergy to local anesthetics
History of recent/current local or generalized infection
Immunocompromised
Significant psychiatric disease
History of opioid dependence
Pregnancy or lactation
A prisoner.
Significant liver disease
Contraindication to ondansetron or dexamethasone
Clinically significant cardiac or pulmonary disease

Contacts and Locations

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:

Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. Review.

Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. Review.

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 June 18, 2013

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