NCT00500565

Brief Summary

The objective of this pilot study is to examine the efficacy of the ON\~Q Pain Relief System plus Intravenous Patient Controlled Analgesia (IVPCA) with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous (TRAM) flap surgery. The primary outcome measure will be postoperative opioid analgesia requirements. Other outcomes will also be assessed, including pain scores, quality of recovery, and resource utilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

2.5 years

First QC Date

July 10, 2007

Last Update Submit

October 10, 2013

Conditions

Breast Cancer

Keywords

Breast CancerOn-Q Pain Relief SystemTransverse Rectus Abdominous MyocutaneousBreast ReconstructionTRAM flapBupivicainePain Management

Outcome Measures

Primary Outcomes (1)

  • Total Postoperative Opioid Use by Patient

    Measurements performed and recorded every 6 hours while patient is hospitalized.

Study Arms (2)

On-Q pump with Saline

EXPERIMENTAL

On-Q Pump with Saline

Drug: Saline

On-Q Pump with Bupivicaine

EXPERIMENTAL

On-Q Pump with bupivicaine

Drug: Bupivicaine

Interventions

SalineDRUG

On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.

On-Q pump with Saline
BupivicaineDRUG

On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.

On-Q Pump with Bupivicaine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with or undergoing unilateral elective free TRAM flap for breast reconstruction, immediate or delayed, with or without a surgical revision of the contralateral breast for asymmetry.
  • American Society of Anesthesiology Physical Status I - III patients.
  • Patients has given voluntary written informed consent before performance of any study-related procedure.

You may not qualify if:

  • Patients undergoing bilateral TRAM flap reconstruction.
  • Patients with a prior allergic reaction to Marcaine (bupivacaine) or other amide local anesthetics.
  • Patients with a prior allergic reaction to Morphine and Hydromorphone.
  • Patients undergoing any other unrelated surgical procedure to the breast reconstruction.
  • Patient refusal to participate.
  • Patient required major abdominal surgery within four weeks prior to enrollment.
  • Patients being treated for chronic pain or using daily intake of opioid analgesics.
  • Patients with a history of abuse of recreational drugs or alcohol.
  • Patients with any laboratory values or underlying disease, which in the investigator's opinion would preclude them from participation in the trial, specifically: (A) significant liver dysfunction (eg. bilirubin, AST and/or ALT \>1.5 times the upper limit of normal value (B) cardiac conduction defects noted by history or on the pre-op screening EKG.
  • Pregnant or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsAgnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Charles E. Butler, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

December 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2008

Last Updated

October 11, 2013

Record last verified: 2013-10

Locations

US(1)