Continuous Bupivacaine Infusion Following Colonic Surgery

Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Abdominal Surgery
• Intervention / Treatment: Drug: Bupivacaine; Drug: Saline

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine; Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)	Drug: Bupivacaine; Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA); Other Names: Marcain, Marcaine,Sensorcaine
Placebo Comparator: Placebo; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue oxygenation	averge tissue oxygenation on wound healing after abdominal surgery	24 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal rating scales (VRS)	0 -10 scale with 0 = no pain and 10 = worst pain	24 hours post surgery

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 13, 2007
• First Submitted That Met QC Criteria: November 13, 2007
• First Posted (Estimate): November 14, 2007

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Surgery; Bupivacaine; Colon; Oxygenation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 07-758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO