NCT00280553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

8 years

First QC Date

January 19, 2006

Last Update Submit

May 14, 2012

Conditions

Laparoscopic Surgical Procedures

Keywords

analgesialaparoscopic surgical procedureslength of stay

Outcome Measures

Primary Outcomes (1)

  • length of stay postoperative in hospital

    end of surgery to discharge

Secondary Outcomes (3)

  • 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

    Post-op 1, 2, 3, 5 and 14

Study Arms (3)

patient controlled analgesia (PCA) only

NO INTERVENTION

PCA and pump with saline infusion for up to five days

OTHER
Other: Saline infusion

PCA and bupivicaine infusion for up to five days

OTHER
Drug: bupivicaine

Interventions

bupivicaineDRUG

PCA and bupivicaine infusion for up to five days

PCA and bupivicaine infusion for up to five days
Saline infusionOTHER

PCA and pump with saline infusion for up to five days

PCA and pump with saline infusion for up to five days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University-St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Publications (8)

  • 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.

    PMID: 15005598BACKGROUND

  • 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.

    PMID: 8519719BACKGROUND

  • 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.

    PMID: 15468395BACKGROUND

  • 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.

    PMID: 14508326BACKGROUND

  • 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.

    PMID: 11260098BACKGROUND

  • 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.

    PMID: 15141043BACKGROUND

  • 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.

    PMID: 11903389BACKGROUND

  • 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.

    PMID: 1235985BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margherita Cadeddu, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margherita Cadeddu, MD

CONTACT

905-522-1155tuitem@mcmaster.ca

Karen Barlow, BSc

CONTACT

905-522-1155kbarlow@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 23, 2006

Study Start

April 1, 2005

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CA(1)