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A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

A Pilot Study of Bupivacaine Infusion in Abdominal Surgery

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00280553
Enrollment
60
Registered
2006-01-23
Start date
2005-04-30
Completion date
2013-04-30
Last updated
2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Surgical Procedures

Keywords

analgesia, laparoscopic surgical procedures, length of stay

Brief 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.

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.

Interventions

PCA and bupivicaine infusion for up to five days

OTHERSaline infusion

PCA and pump with saline infusion for up to five days

Sponsors

McMaster University
CollaboratorOTHER
The Physicians' Services Incorporated Foundation
CollaboratorOTHER
St. Joseph's Healthcare Hamilton
CollaboratorOTHER
Margherita CADDEDU
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
length of stay postoperative in hospitalend of surgery to discharge

Secondary

MeasureTime frame
subjective pain of patientPre-op and post-op
incidence of in-hospital and post-discharge complicationsPost-op days 1, 2, 3, 5 and 14
amount of narcotic and non-narcotic analgesia requiredPost-op 1, 2, 3, 5 and 14

Countries

Canada

Contacts

Primary ContactMargherita Cadeddu, MD
tuitem@mcmaster.ca905-522-1155
Backup ContactKaren Barlow, BSc
kbarlow@mcmaster.ca905-522-1155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026