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CompletedNCT01552226Updated Sep 15, 2025Results posted

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

An interventional study of Continuous Preperitoneal Analgesia and Continuous Epidural Analgesia in Colon Cancer, Rectal Cancer and Colonic Diverticulosis, sponsored by Trinity Health Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Trinity Health Michigan · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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
02

Conditions studied

  • Colon Cancer
  • Rectal Cancer
  • Colonic Diverticulosis
03

In context

Colonic Neoplasms

1,433 studies on the registry are indexed under Colonic Neoplasms; 358 are open to participants now.

This study's enrollment of 98 is close to the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Trinity Health Michigan is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Active comparator
    Continuous Preperitoneal Analgesia (CPA)

    Continuous Preperitoneal Analgesia for pain management

    Device: Continuous Preperitoneal Analgesia

  • Active comparator
    Continuous Epidural Analgesia (CEA)

    Continuous Epidural Analgesia for pain management

    Device: Continuous Epidural Analgesia

Interventions

  • DeviceContinuous Preperitoneal Analgesia

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

    Also known as: On-Q Silver Soaker(tm)

  • DeviceContinuous Epidural Analgesia

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

06

What researchers measure

Primary outcomes

  1. Postoperative Numerical Pain Score-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".

    Time frame: Post-operative day 0

  2. Postoperative Numerical Pain Score-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".

    Time frame: Post-operative day 1

  3. Postoperative Numerical Pain Score-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".

    Time frame: Post-operative day 2

  4. Postoperative Numerical Pain Score-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".

    Time frame: Post-operative day 3

  5. Postoperative Numerical Pain Score-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".

    Time frame: Post-operative day 4

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

    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".

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

Secondary outcomes

  1. Patient Use of Supplemental Narcotic Analgesia Day 1

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

    Time frame: Post-operative day 1

  2. Patient Use of Supplemental Narcotic Analgesia Day 2

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

    Time frame: Post-operative day 2

  3. Patient Use of Supplemental Narcotic Analgesia Day 3

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

    Time frame: Post-operative day 3

  4. Patient Use of Supplemental Narcotic Analgesia Day 4

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

    Time frame: Post-operative day 4

  5. Patient Use of Supplemental Narcotic Analgesia Day 0

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

    Time frame: Post-operative day 0

07

Results

Posted Sep 15, 2025

Participant flow

Participant flow — Overall Study
MilestoneContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Started5048
Completed4644
Not completed44
Withdrew: Withdrawal by subject44

Outcome measures

PrimaryPostoperative Numerical Pain Score-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".

Time frame:
Post-operative day 0
Reported as:
Mean · units on a scale
Postoperative Numerical Pain Score-Day 0
units on a scaleContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Postoperative Numerical Pain Score-Day 03.9 ± 2.02.6 ± 1.7
PrimaryPostoperative Numerical Pain Score-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".

Time frame:
Post-operative day 1
Reported as:
Mean · units on a scale
Postoperative Numerical Pain Score-Day 1
units on a scaleContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Postoperative Numerical Pain Score-Day 13.2 ± 1.82.6 ± 1.9
PrimaryPostoperative Numerical Pain Score-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".

Time frame:
Post-operative day 2
Reported as:
Mean · units on a scale
Postoperative Numerical Pain Score-Day 2
units on a scaleContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Postoperative Numerical Pain Score-Day 22.6 ± 1.72.1 ± 1.7
PrimaryPostoperative Numerical Pain Score-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".

Time frame:
Post-operative day 3
Reported as:
Mean · units on a scale
Postoperative Numerical Pain Score-Day 3
units on a scaleContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Postoperative Numerical Pain Score-Day 32.9 ± 1.92.7 ± 1.9
PrimaryPostoperative Numerical Pain Score-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".

Time frame:
Post-operative day 4
Reported as:
Mean · units on a scale
Postoperative Numerical Pain Score-Day 4
units on a scaleContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Postoperative Numerical Pain Score-Day 43.1 ± 2.12.7 ± 1.8
PrimaryPostoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)

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".

Time frame:
After surgery in the post-anesthesia care unit
Reported as:
Mean · units on a scale
Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)
units on a scaleContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)3.5 ± 2.82.3 ± 2.5
SecondaryPatient Use of Supplemental Narcotic Analgesia Day 1

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

Time frame:
Post-operative day 1
Reported as:
Mean · Morphine equivalents
Patient Use of Supplemental Narcotic Analgesia Day 1
Morphine equivalentsContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Patient Use of Supplemental Narcotic Analgesia Day 129 (20.1 to 41.8)23 (14.4 to 36.4)
SecondaryPatient Use of Supplemental Narcotic Analgesia Day 2

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

Time frame:
Post-operative day 2
Reported as:
Mean · morphine equivalents
Patient Use of Supplemental Narcotic Analgesia Day 2
morphine equivalentsContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Patient Use of Supplemental Narcotic Analgesia Day 222.4 (14.2 to 35.1)21.2 (13.9 to 32.0)
SecondaryPatient Use of Supplemental Narcotic Analgesia Day 3

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

Time frame:
Post-operative day 3
Reported as:
Mean · morphine equivalents
Patient Use of Supplemental Narcotic Analgesia Day 3
morphine equivalentsContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Patient Use of Supplemental Narcotic Analgesia Day 317.4 (10.4 to 28.6)16.0 (10.7 to 23.7)
SecondaryPatient Use of Supplemental Narcotic Analgesia Day 4

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

Time frame:
Post-operative day 4
Reported as:
Mean · morphine equivalents
Patient Use of Supplemental Narcotic Analgesia Day 4
morphine equivalentsContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Patient Use of Supplemental Narcotic Analgesia Day 46.9 (3.7 to 12.3)9.2 (5.1 to 15.9)
SecondaryPatient Use of Supplemental Narcotic Analgesia Day 0

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

Time frame:
Post-operative day 0
Reported as:
Mean · morphine equivalents
Patient Use of Supplemental Narcotic Analgesia Day 0
morphine equivalentsContinuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)
Patient Use of Supplemental Narcotic Analgesia Day 020.5 (14.2 to 29.5)11.0 (7.1 to 16.6)

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Continuous Preperitoneal Analgesia (CPA)—0/50 (0%)0/50 (0%)
Continuous Epidural Analgesia (CEA)—0/48 (0%)0/48 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Mean59.4 ± 12.260.8 ± 12.660.1 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Female182139
Male282351
BMI
BMI(kg/m^2)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Mean29.1 ± 6.629.6 ± 5.929.35 ± 6.25
Tobacco Use
Tobacco Use(Participants)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Count of participants8412
Narcotics use
Narcotics use(Participants)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Count of participants426
Diabetes
Diabetes(Participants)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Count of participants437
Blood thinners
Blood thinners(Participants)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Count of participants336
Primary diagnosis
Primary diagnosis(Participants)Continuous Preperitoneal Analgesia (CPA)Continuous Epidural Analgesia (CEA)Total
Malignancy212445
Diverticulitis191332
Irritable Bowel Disease235
Other448

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Saint Joseph Mercy Hospital
    Ann Arbor, Michigan 48106, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01552226
Lead sponsor
Trinity Health Michigan
Responsible party
Sponsor
First posted
Mar 13, 2012
Start date
Jan 2010
Primary completion
Mar 2015
Completion
Mar 2015
Results posted
Sep 15, 2025
Last update
Sep 15, 2025

Study contacts

Robert Cleary, MD
principal investigator · Trinity Health Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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