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NCT Number: NCT01552226

Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery

This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver Soaker™ catheters (CPA) is equivalent to continuous epidural analgesia (CEA).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

About this study

Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. These techniques, however, are labor-intensive and expensive. Alternatively, local analgesics may be administered directly to the surgical wound via silver catheters.

Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use.

Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. The primary outcomes are post-operative pain control and supplemental narcotic usage.

Other variables of interest

  • Surgical site infections
  • The post-operative time to return of bowel function
  • The hospital expenses/cost differences
  • Quality of life measured with the Short Form (SF)- 36 questionnaire

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > = 18 years
  • Scheduled for elective colon or rectal surgery
  • Surgical procedure either through open laparotomy or via minimal invasive approach (laparoscopic)
  • Able to provide informed consent
  • Able to complete patient questionnaire

Exclusion criteria

  • Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl
  • Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, etc)
  • Urgent surgery precluding epidural catheter placement
  • Systemic Infection contraindicating epidural catheter placement
  • Unwillingness to participate in follow up assessments
  • Prisoners

Treatment and study plan

Continuous Preperitoneal Analgesia

Device

Preperitoneal catheter placed at the completion of surgery in the standard fashion.

Other names: On-Q Silver Soaker(tm)

Continuous Epidural Analgesia

Device

Epidural catheter placed prior to the operation in the standard fashion.

Primary outcomes

  1. Postoperative Numerical Pain Score-Day 0

    Time frame: Post-operative day 0

    Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  2. Postoperative Numerical Pain Score-Day 1

    Time frame: Post-operative day 1

    Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  3. Postoperative Numerical Pain Score-Day 2

    Time frame: Post-operative day 2

    Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  4. Postoperative Numerical Pain Score-Day 3

    Time frame: Post-operative day 3

    Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  5. Postoperative Numerical Pain Score-Day 4

    Time frame: Post-operative day 4

    Measured by the patient using the numerical pain scale (NPS). NPS is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  6. Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)

    Time frame: After surgery in the post-anesthesia care unit

    Postoperative NPS is a pain screening tool, commonly used to assess the pain severity a patient experiences after surgery, where "0" indicates no pain and "10" represents the worst pain imaginable".

Secondary outcomes

  1. Patient Use of Supplemental Narcotic Analgesia Day 1

    Time frame: Post-operative day 1

    Patient use of supplemental narcotic analgesia day 1 measured in morphine equivalents.

  2. Patient Use of Supplemental Narcotic Analgesia Day 2

    Time frame: Post-operative day 2

    Patient use of supplemental narcotic analgesia day 2 measured in morphine equivalents.

  3. Patient Use of Supplemental Narcotic Analgesia Day 3

    Time frame: Post-operative day 3

    Patient use of supplemental narcotic analgesia on day 3, measured in morphine equivalents.

  4. Patient Use of Supplemental Narcotic Analgesia Day 4

    Time frame: Post-operative day 4

    Patient use of supplemental narcotic analgesia day 4 measured in morphine equivalents.

  5. Patient Use of Supplemental Narcotic Analgesia Day 0

    Time frame: Post-operative day 0

    Patient use of supplemental narcotic analgesia day 0 measured in morphine equivalents.

Sponsors and collaborators

Lead sponsor

Trinity Health Michigan

Other

Registry information

Official study title

Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2012
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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