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Continuous Bupivacaine Infusion Following Colonic Surgery

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00557843
First received: November 13, 2007
Last updated: February 28, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Abdominal Surgery
Drug: Bupivacaine
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • Effect of tissue oxygenation on wound healing after abdominal surgery [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the influence of local anesthetic infiltration on pain scores after abdominal surgery [ Time Frame: 24 hours post surgery ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
Drug: Bupivacaine
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
Other Name: Marcain, Marcaine,Sensorcaine
Placebo Comparator: 2
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
Drug: Saline
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)

Detailed Description:

Patients undergoing abdominal surgery will be randomized to one of two groups.

Group 1: Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)

Group 2: Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)

All patients will be premedicated with IV midazolam up to 5 mg. On arrival to the operating room, a fluid bolus of 10 ml/kg/h will be administered before induction of anesthesia.

Those randomized to local wound perfusion will receive the local anesthetic or placebo via the ON-Q pain management system. At the end of surgery a catheter will be positioned in the subcutaneous layer of the wound, leaving via a separate stab incision. The wound closure will then be completed.

A loading dose of local anesthetic solution, 20 ml lidocaine 1% plus 20 ml bupivacaine 0.5%, or, the same amount of placebo will be injected into the wound before the patient leaves the operating room. Thereafter bupivacaine 0.5% alone or placebo will be injected continuously into the wound at a flow rate of 2 ml/h for 24 hours.

Subcutaneous oxygen tension (PsqO2) will be evaluated intraoperatively with a polygraphic-type tissue oxygen sensor positioned within a subcutaneous, saline filled Silastic® tonometer inserted into the patients' upper arm after induction of anesthesia.

Postoperative pain relief will be maintained by patient-controlled analgesia (PCA) with morphine (2mg bolus, 6-minute lock-out) and with local anesthetic wound perfusion.

Patients will be given supplemental oxygen via a face mask at a rate of 2 L/min. Additional oxygen will be given as necessary to maintain an oxygen saturation > 95%.

An observer blinded to group assignment will perform all the postoperative evaluations.

Patient chart review will be undertaken to screen for evidence of surgical wound infection. The presence of infection will be determined by review of the attending surgeon's documentation in the patient's chart.

  Eligibility

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

Inclusion Criteria:

  1. 18-80 years of age.
  2. The patient has provided written informed consent.
  3. The patient is scheduled for abdominal surgery.
  4. The patient has an ASA of I, II, or III.
  5. The patient understands the explanation of the protocol.

Exclusion Criteria:

  1. Patients aged < 18 and > 80 years.
  2. History of diabetes mellitus.
  3. History of congestive heart failure.
  4. History of peripheral vascular disease.
  5. History of smoking.
  6. History of Dysautonomia.
  7. History of thyroid disease.
  8. Susceptibility to malignant hyperthermia.
  9. History of morbid obesity.
  10. History of fever
  11. History of infection.
  12. Contraindication to the placement of an arterial line; e.g., Raynaud's disease.
  13. The patient declines participation.
  14. Any patient the investigator feels is not a candidate for this study.
  15. Any patient with a history of known alcohol, analgesic, or narcotic substance abuse within two years of screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557843

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Andrea Kurz, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Andrea Kurz, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00557843     History of Changes
Other Study ID Numbers: 07-758
Study First Received: November 13, 2007
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Bupivacaine
Colon
Surgery
Oxygenation

Additional relevant MeSH terms:
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014