Continuous Bupivacaine Infusion Following Colonic Surgery

NCT00557843 | Withdrawn

• 1 other identifier: 07-758
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to evaluate the influence of continuous local anesthetic infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a major predictor for wound healing.

Conditions

Abdominal Surgery

Keywords

Bupivacaine; Colon; Surgery; Oxygenation

Outcome Measures

Primary Outcomes (1)

• tissue oxygenation

  averge tissue oxygenation on wound healing after abdominal surgery

  24 hours post surgery

Secondary Outcomes (1)

• Verbal rating scales (VRS)

  24 hours post surgery

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)

Drug: Saline

Interventions

Bupivacaine DRUG

Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)

Also known as: Marcain, Marcaine,Sensorcaine

bupivacaine

Saline DRUG

Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• The patient has provided written informed consent.
• The patient is scheduled for abdominal surgery.
• The patient has an ASA of I, II, or III.
• The patient understands the explanation of the protocol.

You may not qualify if:

• Patients aged \< 18 and \> 80 years.
• History of diabetes mellitus.
• History of congestive heart failure.
• History of peripheral vascular disease.
• History of smoking.
• History of Dysautonomia.
• History of thyroid disease.
• Susceptibility to malignant hyperthermia.
• History of morbid obesity.
• History of fever
• History of infection.
• Contraindication to the placement of an arterial line; e.g., Raynaud's disease.
• The patient declines participation.
• Any patient the investigator feels is not a candidate for this study.
• Any patient with a history of known alcohol, analgesic, or narcotic substance abuse within two years of screening.

Sponsors & Collaborators

• The Cleveland Clinic: lead

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Andrea Kurz, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 21, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share