A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

NCT ID: NCT00280553

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2013-04-30

Brief Summary

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.

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.

Conditions

Laparoscopic Surgical Procedures

Study Design

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

Study Groups

patient controlled analgesia (PCA) only

Group Type: NO_INTERVENTION

No interventions assigned to this group

PCA and pump with saline infusion for up to five days

Group Type: OTHER

Saline infusion

Intervention Type: OTHER

PCA and pump with saline infusion for up to five days

PCA and bupivicaine infusion for up to five days

Group Type: OTHER

bupivicaine

Intervention Type: DRUG

PCA and bupivicaine infusion for up to five days

Interventions

bupivicaine

PCA and bupivicaine infusion for up to five days

Intervention Type: DRUG

Saline infusion

PCA and pump with saline infusion for up to five days

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: collaborator

Margherita CADDEDU

OTHER

Sponsor Role: lead

Responsible Party

Margherita CADDEDU

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Margherita Cadeddu, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University-St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Margherita Cadeddu, MD

Role: CONTACT

tuitem@mcmaster.ca

905-522-1155 ext. 4990

Karen Barlow, BSc

Role: CONTACT

kbarlow@mcmaster.ca

905-522-1155 ext. 35067

Facility Contacts

Margherita Cadeddu, MD

Role: primary

tuitem@mcmaster.ca

905-522-1155 ext. 34990

Karen Barlow

Role: backup

kbarlow@mcmaster.ca

905-522-1155 ext. 35067

References

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Reference Type: BACKGROUND

PMID: 15005598 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 1235985 (View on PubMed)

Other Identifiers

04-2399

Identifier Type: -

Identifier Source: org_study_id