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| Name | Class |
|---|---|
| McMaster University | OTHER |
| The Physicians' Services Incorporated Foundation | OTHER |
| St. Joseph's Healthcare Hamilton | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient controlled analgesia (PCA) only | No Intervention | ||
| PCA and pump with saline infusion for up to five days | Other |
| |
| PCA and bupivicaine infusion for up to five days | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivicaine | Drug | PCA and bupivicaine infusion for up to five days |
|
| Measure | Description | Time Frame |
|---|---|---|
| length of stay postoperative in hospital | end of surgery to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| subjective pain of patient | Pre-op and post-op | |
| incidence of in-hospital and post-discharge complications | Post-op days 1, 2, 3, 5 and 14 | |
| amount of narcotic and non-narcotic analgesia required |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margherita Cadeddu, MD | Contact | 905-522-1155 | 4990 | tuitem@mcmaster.ca |
| Karen Barlow, BSc | Contact | 905-522-1155 | 35067 | kbarlow@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Margherita Cadeddu, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University-St. Joseph's Healthcare | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15005598 | Background | Skinner HB, Shintani EY. Results of a multimodal analgesic trial involving patients with total hip or total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2004 Feb;33(2):85-92; discussion 92. | |
| 8519719 | Background | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Saline infusion | Other | PCA and pump with saline infusion for up to five days |
|
| Post-op 1, 2, 3, 5 and 14 |
| 15468395 | Background | 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. doi: 10.1097/01.prs.0000133173.71201.3c. |
| 14508326 | Background | 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. doi: 10.1097/00000542-200310000-00026. |
| 11260098 | Background | 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. doi: 10.1046/j.1365-2168.2001.01717.x. |
| 15141043 | Background | Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651. |
| 11903389 | Background | 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. doi: 10.1034/j.1399-0012.2001.00011.x. |
| 1235985 | Background | Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |