A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

May 14, 2012 updated by: Margherita CADDEDU

The incisions used in abdominal surgery can be quite painful, requiring strong pain medications. A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery.

The main research question is whether use of the pain pump will result in decreased hospital length of stay. The research is important because if the pain pump is found to be effective, it can substantially decrease the length of stay. Areas to be studied include hospital length of stay, patient's comfort post-operatively, and post-operative complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pain in the post-operative period has been a limiting factor delaying recovery following abdominal surgery. Furthermore, it has been associated with several complications including ileus, urinary retention, delay to tolerating oral intake and enteral feeds, thrombo-embolic complications, and respiratory complications such as atelectasis and pneumonia. Diminishing pain in the post-operative period has been a subject of great study and to date the role of epidural analgesia, epidural anesthesia, patient controlled anesthesia and narcotic analgesia has been well documented to assist in controlling pain, decreasing morbidity and accelerating recovery in the post-operative period following colorectal surgery.

Nevertheless, the use of opioid-based analgesic techniques via epidural, nurse or patient controlled delivery systems either oral or parenteral can produce adverse effects such as nausea, vomiting, ileus, delay in tolerance or urinary retention. Concomitant use of non-narcotic based analgesics have failed to obviate the need for narcotic based analgesia. Recently, several companies have developed devices that deliver a constant rate of local anesthetic via a spring loaded device through a multiport catheter inserted into the incision. The effectiveness of these bupivicaine infusion pumps has been demonstrated to diminish post-operative pain following orthopedic, plastic, thoracic and cardiac surgeries but to date their role has not been evaluated in colorectal surgery or abdominal surgery.

The rational of the study is that bupivicaine infusion pumps are being used at St. Joseph's Healthcare for patients undergoing laparoscopic assisted colorectal surgery, and anecdotally, the patients have less pain, need less narcotics and can ambulate and be discharged sooner. This pilot study aims to gather prospective randomized data regarding post-operative length of stay and patient pain scores so that a properly powered randomization study can be undertaken to understand if the bupivicaine infusion system helps decrease length of stay and patient's post-operative pain.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • McMaster University-St. Joseph's Healthcare
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mehran Anvari, MB BS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • eligible and consented patients between the ages of 18 and 80
  • male and female patients
  • scheduled for elective laparoscopic colorectal resection
  • anesthetist-assessed to be ASA 1-3

Exclusion Criteria:

  • patients with allergies to medications used in study
  • non-ambulatory patients
  • patients with foreign bodies (ie. Orthopedics prostheses)
  • patients requiring colostomies as part of procedure
  • patients with enterocutaneous, entero-enteric, enterovaginal, enterovesicular, recto-vaginal, entero-utero fistulas
  • pregnant patients
  • immuno-compromised patients
  • patients with moderate to severe ascites or moderate to severe hepatic insufficiency
  • patients unable to speak and comprehend English
  • patients requiring emergency colorectal resection
  • patients who, for medical reasons assessed by an anesthetist, are deemed deserving of epidural analgesia
  • patients with seizure disorders
  • patients assessed by an anesthetist to be ASA 4 or 5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: patient controlled analgesia (PCA) only
Other: PCA and pump with saline infusion for up to five days
Other: Saline infusion
PCA and pump with saline infusion for up to five days
Other: PCA and bupivicaine infusion for up to five days
Drug: bupivicaine
PCA and bupivicaine infusion for up to five days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of stay postoperative in hospital
Time Frame: end of surgery to discharge
end of surgery to discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
subjective pain of patient
Time Frame: Pre-op and post-op
Pre-op and post-op
incidence of in-hospital and post-discharge complications
Time Frame: Post-op days 1, 2, 3, 5 and 14
Post-op days 1, 2, 3, 5 and 14
amount of narcotic and non-narcotic analgesia required
Time Frame: Post-op 1, 2, 3, 5 and 14
Post-op 1, 2, 3, 5 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Margherita CADDEDU

Collaborators

St. Joseph's Healthcare Hamilton
McMaster University
The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Margherita Cadeddu, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe