Continuous Bupivacaine Infusion Following Colonic Surgery

NCT ID: NCT00557843

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-06-30

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.

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.

Conditions

Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Other Intervention Names

Marcain, Marcaine,Sensorcaine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Kurz, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Other Identifiers

07-758

Identifier Type: -

Identifier Source: org_study_id