A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00280553|
Recruitment Status : Unknown
Verified May 2012 by Margherita CADDEDU, McMaster University.
Recruitment status was: Recruiting
First Posted : January 23, 2006
Last Update Posted : May 15, 2012
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 or disease||Intervention/treatment||Phase|
|Laparoscopic Surgical Procedures||Drug: bupivicaine Other: Saline infusion||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pilot Study of Bupivacaine Infusion in Abdominal Surgery|
|Study Start Date :||April 2005|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||April 2013|
|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
- length of stay postoperative in hospital [ Time Frame: end of surgery to discharge ]
- subjective pain of patient [ Time Frame: Pre-op and post-op ]
- incidence of in-hospital and post-discharge complications [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280553
|Contact: Margherita Cadeddu, MD||905-522-1155 ext firstname.lastname@example.org|
|Contact: Karen Barlow, BSc||905-522-1155 ext email@example.com|
|McMaster University-St. Joseph's Healthcare||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Margherita Cadeddu, MD 905-522-1155 ext 34990 firstname.lastname@example.org|
|Contact: Karen Barlow 905-522-1155 ext 35067 email@example.com|
|Principal Investigator: Margherita Cadeddu, MD|
|Sub-Investigator: Mehran Anvari, MB BS, PhD|
|Sub-Investigator: Monali Misra, MD|
|Principal Investigator:||Margherita Cadeddu, MD||McMaster University|