NCT01411917

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

August 4, 2011

Results QC Date

May 21, 2018

Last Update Submit

June 7, 2019

Conditions

Ileostomy - Stoma

Keywords

surgical stomasNerve block

Outcome Measures

Primary Outcomes (1)

  • 24 Hour Postoperative Opioid Consumption

    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.

    24 hours

Secondary Outcomes (7)

  • Pain Scores at Post-anesthesia Care Unit (PACU) Discharge

    Surgical PACU (Approximately 2 hours post-anesthesia)

  • Pain Scores at 24 Hours Post-block

    24 hours post-block

  • Time From PACU Recovery Room Admission Until Meeting Recovery Room Discharge Criteria

    Approximately two hours post-anesthesia

  • Intra-operative Opioid Use

    Approximately 2-3 hours after block/placebo placement

  • PACU Opioid Use

    Approximately two hours post-anesthesia

  • +2 more secondary outcomes

Study Arms (2)

TAP block group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Patients in this group will have an ultrasound guided subcutaneous injection of 30 ml of sterile preservative free saline.

Procedure: Transversus abdominis plane block

Interventions

Transversus abdominis plane blockPROCEDURE

Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.

PlaceboTAP block group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • 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. doi: 10.1016/j.jclinane.2010.05.008.

    PMID: 21296242RESULT

  • 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. doi: 10.1002/14651858.CD007705.pub2.

    PMID: 21154380RESULT

Results Point of Contact

Title
Kristopher Schroeder
Organization
University of Wisconsin School of Medicine, Department of Anesthesiology
kmschro1@wisc.edu
608-232-1542

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 8, 2011

Study Start

August 1, 2011

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

June 10, 2019

Results First Posted

June 10, 2019

Record last verified: 2019-06

Locations

US(1)