A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
McMaster University
The Physicians' Services Incorporated Foundation
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Margherita CADDEDU, McMaster University
ClinicalTrials.gov Identifier:
NCT00280553
First received: January 19, 2006
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Laparoscopic Surgical Procedures
Drug: bupivicaine
Other: Saline infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • length of stay postoperative in hospital [ Time Frame: end of surgery to discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective pain of patient [ Time Frame: Pre-op and post-op ] [ Designated as safety issue: No ]
  • incidence of in-hospital and post-discharge complications [ Time Frame: Post-op days 1, 2, 3, 5 and 14 ] [ Designated as safety issue: Yes ]
  • amount of narcotic and non-narcotic analgesia required [ Time Frame: Post-op 1, 2, 3, 5 and 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: patient controlled analgesia (PCA) only
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
PCA and bupivicaine infusion for up to five days Drug: bupivicaine
PCA and bupivicaine infusion for up to five days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280553

Contacts
Contact: Margherita Cadeddu, MD 905-522-1155 ext 4990 tuitem@mcmaster.ca
Contact: Karen Barlow, BSc 905-522-1155 ext 35067 kbarlow@mcmaster.ca

Locations
Canada, Ontario
McMaster University-St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Margherita Cadeddu, MD    905-522-1155 ext 34990    tuitem@mcmaster.ca   
Contact: Karen Barlow    905-522-1155 ext 35067    kbarlow@mcmaster.ca   
Principal Investigator: Margherita Cadeddu, MD         
Sub-Investigator: Mehran Anvari, MB BS, PhD         
Sub-Investigator: Monali Misra, MD         
Sponsors and Collaborators
Margherita CADDEDU
McMaster University
The Physicians' Services Incorporated Foundation
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Margherita Cadeddu, MD McMaster University
  More Information

Publications:

Responsible Party: Margherita CADDEDU, MD, McMaster University
ClinicalTrials.gov Identifier: NCT00280553     History of Changes
Other Study ID Numbers: 04-2399
Study First Received: January 19, 2006
Last Updated: May 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
analgesia
laparoscopic surgical procedures
length of stay

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014