Recruiting
Phase 2

Pain Pump

Sponsor:

Margherita CADDEDU

Code:

NCT00280553

Conditions

Laparoscopic Surgical Procedures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

bupivicaine

Saline infusion

Study Details

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.

Conditions

Laparoscopic Surgical Procedures

Study ID

NCT00280553

Start date

Apr, 2005

Status verified date

May, 2012

Completion date

Apr, 2013

Anticipated

Primary completion date

Apr, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: patient controlled analgesia (PCA) only

other: PCA and pump with saline infusion for up to five days

other: PCA and bupivicaine infusion for up to five days

Interventions

bupivicaine

PCA and bupivicaine infusion for up to five days

Saline infusion

PCA and pump with saline infusion for up to five days

Primary outcome measure

  • length of stay postoperative in hospital [ Time Frame: end of surgery to discharge ]

Central Contacts and Locations

Central contacts

Margherita Cadeddu, MD

905-522-1155tuitem@mcmaster.ca

Karen Barlow, BSc

905-522-1155kbarlow@mcmaster.ca

Locations

McMaster University-St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Margherita Cadeddu, MD

905-522-1155tuitem@mcmaster.ca

Karen Barlow

905-522-1155kbarlow@mcmaster.ca

Principal Investigator:

Margherita Cadeddu, MD

More Information

Sponsor

Margherita CADDEDU

Last update posted

May 15, 2012

Last verified

May, 2012

Keywords

  • analgesia
  • laparoscopic surgical procedures
  • length of stay

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Margherita CADDEDU on 2012-05-15.