Clinical trial NCT00557843: Continuous Bupivacaine Infusion Following Colonic Surgery
Official title: Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdominal Surgery
Keywords: Bupivacaine
Colon
Surgery
Oxygenation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: tissue oxygenation
timeFrame: 24 hours post surgery
Secondary outcomes:
measure: Verbal rating scales (VRS)
timeFrame: 24 hours post surgery
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Andrea Kurz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: