Continuous Bupivacaine Infusion Following Colonic Surgery

Abdominal Surgery Clinical Trial

Official title:

Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00557843
• Other study ID #: 07-758
• Status: Withdrawn
• Phase: N/A
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgery

Intervention

Drug:
• Bupivacaine
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
• Saline
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tissue oxygenation	averge tissue oxygenation on wound healing after abdominal surgery	24 hours post surgery
Secondary	Verbal rating scales (VRS)	0 -10 scale with 0 = no pain and 10 = worst pain	24 hours post surgery