A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

Laparoscopic Surgical Procedures Clinical Trial

Official title:

A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00280553
• Other study ID #: 04-2399
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2006
• Last updated: May 14, 2012
• Start date: April 2005
• Est. completion date: April 2013

Study information

• Verified date: May 2012
• Source: McMaster University
• Contact: Margherita Cadeddu, MD
• Phone: 905-522-1155
• Email: tuitem[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedures

Intervention

Drug:
• bupivicaine
PCA and bupivicaine infusion for up to five days

Other:
• Saline infusion
PCA and pump with saline infusion for up to five days

Locations

Country	Name	City	State
Canada	McMaster University-St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Margherita CADDEDU	McMaster University, St. Joseph's Healthcare Hamilton, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay postoperative in hospital		end of surgery to discharge	No
Secondary	subjective pain of patient		Pre-op and post-op	No
Secondary	incidence of in-hospital and post-discharge complications		Post-op days 1, 2, 3, 5 and 14	Yes
Secondary	amount of narcotic and non-narcotic analgesia required		Post-op 1, 2, 3, 5 and 14	No