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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Active Comparator | Continuous Preperitoneal Analgesia for pain management |
|
| Continuous Epidural Analgesia (CEA) | Active Comparator | Continuous Epidural Analgesia for pain management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Preperitoneal Analgesia | Device | Preperitoneal catheter placed at the completion of surgery in the standard fashion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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". | 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". | 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". | 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". | Post-operative day 4 |
| Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Use of Supplemental Narcotic Analgesia Day 1 | Patient use of supplemental narcotic analgesia day 1 measured in morphine equivalents. | Post-operative day 1 |
| Patient Use of Supplemental Narcotic Analgesia Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Cleary, MD | Trinity Health Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
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| Label | URL |
|---|---|
| American Society of Colon and Rectal Surgeons | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Preperitoneal Analgesia (CPA) | Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion. |
| FG001 | Continuous Epidural Analgesia (CEA) | Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Preperitoneal Analgesia (CPA) | Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion. |
| BG001 | Continuous Epidural Analgesia (CEA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 0 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Preperitoneal Analgesia (CPA) | Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Cleary | St. Joseph Mercy Hospital Ann Arbor | 7347128150 | Robert.Cleary@trinity-health.org |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D043963 | Diverticulosis, Colonic |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| Continuous Epidural Analgesia | Device | Epidural catheter placed prior to the operation in the standard fashion. |
|
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". |
| After surgery in the post-anesthesia care unit |
Patient use of supplemental narcotic analgesia day 2 measured in morphine equivalents.
| 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. | Post-operative day 3 |
| Patient Use of Supplemental Narcotic Analgesia Day 4 | Patient use of supplemental narcotic analgesia day 4 measured in morphine equivalents. | Post-operative day 4 |
| Patient Use of Supplemental Narcotic Analgesia Day 0 | Patient use of supplemental narcotic analgesia day 0 measured in morphine equivalents. | Post-operative day 0 |
Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Body Mass Index (BMI) is measured by a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. | Mean | Standard Deviation | kg/m^2 |
|
| Tobacco Use | Count of Participants | Participants |
|
| Narcotics use | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Blood thinners | Count of Participants | Participants |
|
| Primary diagnosis | Count of Participants | Participants |
|
| Surgical approach | Count of Participants | Participants |
|
| Procedure Type | Count of Participants | Participants |
|
| Wound class II, clean contaminated | Patients are "graded" based on standardized definitions of wound classes and are assigned these grades during debriefing after skin closure. This grade is then documented in the patient record. Class II/Clean-Contaminated: An operative wound in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Specifically, operations involving the biliary tract, appendix, vagina, and oropharynx are included in this category, provided no evidence of infection or major break in a sterile technique is encountered. | Count of Participants | Participants |
|
| Preoperative Short Form Health Survey (SF-36 subscale) | Preoperative Short Form Health Survey refers to a set of questions from the SF-36 that a patient completes before a surgical procedure, with an overall aggregate scale and eight subscales. The subscales assess aspects of their health status, including physical functioning, bodily pain, role limitations due to physical health, social functioning, mental health, vitality, and general health perceptions, allowing healthcare providers to understand the patient's baseline health condition before surgery. Each subscale is scored on a scale from 0 to 100, with higher scores indicating better health. | The numbers are different due to the difference in number of respondents on some of the sub scales. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Continuous Epidural Analgesia (CEA) |
Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion. |
|
|
| Primary | 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". | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 1 |
|
|
|
| Primary | 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". | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 2 |
|
|
|
| Primary | 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". | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 3 |
|
|
|
| Primary | 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". | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Standard Deviation | units on a scale | Post-operative day 4 |
|
|
|
| Primary | 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". | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Standard Deviation | units on a scale | After surgery in the post-anesthesia care unit |
|
|
|
| Secondary | Patient Use of Supplemental Narcotic Analgesia Day 1 | Patient use of supplemental narcotic analgesia day 1 measured in morphine equivalents. | "The Overall Number of Participants Analyzed" is not consistent with the numbers provided in the Participant Flow module due to the difference in the number of respondents on the scale. | Posted | Mean | Full Range | Morphine equivalents | Post-operative day 1 |
|
|
|
| Secondary | Patient Use of Supplemental Narcotic Analgesia Day 2 | Patient use of supplemental narcotic analgesia day 2 measured in morphine equivalents. | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Full Range | morphine equivalents | Post-operative day 2 |
|
|
|
| Secondary | Patient Use of Supplemental Narcotic Analgesia Day 3 | Patient use of supplemental narcotic analgesia on day 3, measured in morphine equivalents. | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Full Range | morphine equivalents | Post-operative day 3 |
|
|
|
| Secondary | Patient Use of Supplemental Narcotic Analgesia Day 4 | Patient use of supplemental narcotic analgesia day 4 measured in morphine equivalents. | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Full Range | morphine equivalents | Post-operative day 4 |
|
|
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| Secondary | Patient Use of Supplemental Narcotic Analgesia Day 0 | Patient use of supplemental narcotic analgesia day 0 measured in morphine equivalents. | The Overall Number of Participants Analyzed is not consistent with the numbers provided in the Participant Flow module. This discrepancy is due to the difference in the number of respondents on this scale for this timeframe. | Posted | Mean | Full Range | morphine equivalents | Post-operative day 0 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Continuous Epidural Analgesia (CEA) | Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion. | 0 | 48 | 0 | 48 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |