A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
Recruitment status was Recruiting
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.
Laparoscopic Surgical Procedures
Other: Saline infusion
|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|
- length of stay postoperative in hospital [ Time Frame: end of surgery to discharge ] [ Designated as safety issue: No ]
- 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 ]
|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)|
|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||
PCA and bupivicaine infusion for up to five days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280553
|Contact: Margherita Cadeddu, MD||905-522-1155 ext email@example.com|
|Contact: Karen Barlow, BSc||905-522-1155 ext firstname.lastname@example.org|
|McMaster University-St. Joseph's Healthcare||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Margherita Cadeddu, MD 905-522-1155 ext 34990 email@example.com|
|Contact: Karen Barlow 905-522-1155 ext 35067 firstname.lastname@example.org|
|Principal Investigator: Margherita Cadeddu, MD|
|Sub-Investigator: Mehran Anvari, MB BS, PhD|
|Sub-Investigator: Monali Misra, MD|
|Principal Investigator:||Margherita Cadeddu, MD||McMaster University|