Colon CancerNCT01552226
Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
A study testing Continuous Preperitoneal Analgesia and Continuous Epidural Analgesia in people with Colon Cancer and Rectal Cancer, run by Trinity Health Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- What is being tested?
- Continuous Preperitoneal Analgesia and Continuous Epidural Analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
About this study
Official title: Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous 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).
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
- Conditions
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- Being tested
- Continuous Preperitoneal Analgesia, Continuous Epidural Analgesia
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Preperitoneal AnalgesiaDevice
Also called On-Q Silver Soaker(tm)
Preperitoneal catheter placed at the completion of surgery in the standard fashion.
Continuous Epidural AnalgesiaDevice
Epidural catheter placed prior to the operation in the standard fashion.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Active comparator | Continuous Preperitoneal Analgesia for pain management Receives: Device: Continuous Preperitoneal Analgesia |
| Continuous Epidural Analgesia (CEA) | Active comparator | Continuous Epidural Analgesia for pain management Receives: Device: Continuous Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Post-operative day 0
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".
Measured: Post-operative day 1
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".
Measured: Post-operative day 2
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".
Measured: Post-operative day 3
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".
Measured: Post-operative day 4
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".
Measured: After surgery in the post-anesthesia care unit
Secondary outcomes (5)
Patient Use of Supplemental Narcotic Analgesia Day 1
Patient use of supplemental narcotic analgesia day 1 measured in morphine equivalents.
Measured: Post-operative day 1
Patient Use of Supplemental Narcotic Analgesia Day 2
Patient use of supplemental narcotic analgesia day 2 measured in morphine equivalents.
Measured: Post-operative day 2
Patient Use of Supplemental Narcotic Analgesia Day 3
Patient use of supplemental narcotic analgesia on day 3, measured in morphine equivalents.
Measured: Post-operative day 3
Patient Use of Supplemental Narcotic Analgesia Day 4
Patient use of supplemental narcotic analgesia day 4 measured in morphine equivalents.
Measured: Post-operative day 4
Patient Use of Supplemental Narcotic Analgesia Day 0
Patient use of supplemental narcotic analgesia day 0 measured in morphine equivalents.
Measured: Post-operative day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cleary, MD, Principal investigator, Trinity Health Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552226
- Sponsor's protocol ID
- RCNM 114
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2012
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery
- ClinicalTrials.gov ID
- NCT01552226
- Acronym / sponsor ID
- RCNM 114
- Conditions
- Colon Cancer, Rectal Cancer, Colonic Diverticulosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Trinity Health MichiganUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Active comparator | Device: Continuous Preperitoneal AnalgesiaContinuous Preperitoneal Analgesia for pain management |
| Continuous Epidural Analgesia (CEA) | Active comparator | Device: Continuous Epidural AnalgesiaContinuous Epidural Analgesia for pain management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Preperitoneal AnalgesiaAlso: On-Q Silver Soaker(tm)Preperitoneal catheter placed at the completion of surgery in the standard fashion. | Device | Continuous Preperitoneal Analgesia (CPA) |
| Continuous Epidural AnalgesiaEpidural catheter placed prior to the operation in the standard fashion. | Device | Continuous Epidural Analgesia (CEA) |
Primary outcome
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".
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".
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".
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".
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".
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".
5 secondary outcomes
Patient Use of Supplemental Narcotic Analgesia Day 1
Time frame: Post-operative day 1
Patient Use of Supplemental Narcotic Analgesia Day 2
Time frame: Post-operative day 2
Patient Use of Supplemental Narcotic Analgesia Day 3
Time frame: Post-operative day 3
Patient Use of Supplemental Narcotic Analgesia Day 4
Time frame: Post-operative day 4
Patient Use of Supplemental Narcotic Analgesia Day 0
Time frame: Post-operative day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- American Society of Colon and Rectal SurgeonsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Cleary, MD principal investigator
Trinity Health Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Preperitoneal Analgesia and Continuous Epidural Analgesia in people with Colon Cancer and Rectal Cancer, run by Trinity Health Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Numerical Pain Score-Day 0 (time frame: Post-operative day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.