A Pilot Study of Bupivacaine Infusion in Abdominal Surgery - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences The Physicians' Services Incorporated Foundation
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00280553

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	Phase II

Drug Information available for: Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

Further study details as provided by McMaster University:

Primary Outcome Measures:

length of stay postoperative in hospital

Secondary Outcome Measures:

subjective pain of patient
incidence of in-hospital and post-discharge complications
amount of narcotic and non-narcotic analgesia required

Estimated Enrollment:	60
Study Start Date:	April 2005
Estimated Study Completion Date:	October 2007

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

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: Catherine Gill Pottruff, BSc	905-522-1155 ext 5296	gillc@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 4990 tuitem@mcmaster.ca
Contact: Karen Barlow, BSc 905-522-1155 ext 5067
Principal Investigator: Margherita Cadeddu, MD
Sub-Investigator: Mehran Anvari, MB BS, PhD
Sub-Investigator: Monali Misra, MD

Sponsors and Collaborators

Hamilton Health Sciences

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator:

Margherita Cadeddu, MD

McMaster University

More Information

Publications:

Skinner HB, Shintani EY. Results of a multimodal analgesic trial involving patients with total hip or total knee arthroplasty. Am J Orthop. 2004 Feb;33(2):85-92; discussion 92.

Carabine UA, Gilliland H, Johnston JR, McGuigan J. Pain relief for thoracotomy. Comparison of morphine requirements using an extrapleural infusion of bupivacaine. Reg Anesth. 1995 Sep-Oct;20(5):412-7.

Baroody M, Tameo MN, Dabb RW. Efficacy of the pain pump catheter in immediate autologous breast reconstruction. Plast Reconstr Surg. 2004 Sep 15;114(4):895-8; discussion 899-900.

White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23.

Cheong WK, Seow-Choen F, Eu KW, Tang CL, Heah SM. Randomized clinical trial of local bupivacaine perfusion versus parenteral morphine infusion for pain relief after laparotomy. Br J Surg. 2001 Mar;88(3):357-9.

Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9.

Ashcraft EE, Baillie GM, Shafizadeh SF, McEvoy JR, Mohamed HK, Lin A, Baliga PK, Rogers J, Rajagopalan PR, Chavin KD. Further improvements in laparoscopic donor nephrectomy: decreased pain and accelerated recovery. Clin Transplant. 2001;15 Suppl 6:59-61.

Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-99.

Study ID Numbers:	04-2399
Study First Received:	January 19, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00280553
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

analgesia
laparoscopic surgical procedures
length of stay

Study placed in the following topic categories:

Bupivacaine

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 15, 2009