Colon Cancer, Rectal Cancer, Colonic Diverticulosis
Conditions
Brief 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).
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
Interventions
DEVICEContinuous Preperitoneal Analgesia
Preperitoneal catheter placed at the completion of surgery in the standard fashion.
Epidural catheter placed prior to the operation in the standard fashion.
Sponsors
Trinity Health Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU) | 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. |
| Postoperative Numerical Pain Score-Day 0 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Use of Supplemental Narcotic Analgesia Day 0 | Post-operative day 0 | Patient use of supplemental narcotic analgesia day 0 measured in morphine equivalents. |
| Patient Use of Supplemental Narcotic Analgesia Day 1 | Post-operative day 1 | Patient use of supplemental narcotic analgesia day 1 measured in morphine equivalents. |
| Patient Use of Supplemental Narcotic Analgesia Day 2 | Post-operative day 2 | Patient use of supplemental narcotic analgesia day 2 measured in morphine equivalents. |
| Patient Use of Supplemental Narcotic Analgesia Day 3 | Post-operative day 3 | Patient use of supplemental narcotic analgesia on day 3, measured in morphine equivalents. |
| Patient Use of Supplemental Narcotic Analgesia Day 4 | Post-operative day 4 | Patient use of supplemental narcotic analgesia day 4 measured in morphine equivalents. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Continuous Epidural Analgesia (CEA) Continuous Epidural Analgesia for pain management
Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion. | 44 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Continuous Epidural Analgesia (CEA) | Continuous Preperitoneal Analgesia (CPA) | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 12.6 | 59.4 years STANDARD_DEVIATION 12.2 | 60.1 years STANDARD_DEVIATION 12.4 |
| Blood thinners | 3 Participants | 3 Participants | 6 Participants |
| BMI | 29.6 kg/m^2 STANDARD_DEVIATION 5.9 | 29.1 kg/m^2 STANDARD_DEVIATION 6.6 | 29.35 kg/m^2 STANDARD_DEVIATION 6.25 |
| Diabetes | 3 Participants | 4 Participants | 7 Participants |
| Narcotics use | 2 Participants | 4 Participants | 6 Participants |
| Preoperative Short Form Health Survey (SF-36 subscale) Aggregate score | 67.0 units on a scale STANDARD_DEVIATION 17.9 | 74.7 units on a scale STANDARD_DEVIATION 14.6 | 70.8 units on a scale STANDARD_DEVIATION 16.2 |
| Preoperative Short Form Health Survey (SF-36 subscale) Emotional | 64.6 units on a scale STANDARD_DEVIATION 19 | 69.5 units on a scale STANDARD_DEVIATION 13.2 | 67.0 units on a scale STANDARD_DEVIATION 16.1 |
| Preoperative Short Form Health Survey (SF-36 subscale) Energy | 55.3 units on a scale STANDARD_DEVIATION 18.8 | 61.8 units on a scale STANDARD_DEVIATION 17 | 58.5 units on a scale STANDARD_DEVIATION 17.9 |
| Preoperative Short Form Health Survey (SF-36 subscale) General health | 65.4 units on a scale STANDARD_DEVIATION 21 | 70.7 units on a scale STANDARD_DEVIATION 19.1 | 68.0 units on a scale STANDARD_DEVIATION 20 |
| Preoperative Short Form Health Survey (SF-36 subscale) Pain | 74.1 units on a scale STANDARD_DEVIATION 23.4 | 76.4 units on a scale STANDARD_DEVIATION 27.5 | 75.2 units on a scale STANDARD_DEVIATION 25.4 |
| Preoperative Short Form Health Survey (SF-36 subscale) Physical functioning | 73.3 units on a scale STANDARD_DEVIATION 26 | 83.3 units on a scale STANDARD_DEVIATION 21.4 | 78.3 units on a scale STANDARD_DEVIATION 23.7 |
| Preoperative Short Form Health Survey (SF-36 subscale) Role limitations: emotional problems | 60.0 units on a scale STANDARD_DEVIATION 54.8 | 75.0 units on a scale STANDARD_DEVIATION 50 | 67.5 units on a scale STANDARD_DEVIATION 52.4 |
| Preoperative Short Form Health Survey (SF-36 subscale) Role limitations: physical health | 55.0 units on a scale STANDARD_DEVIATION 49.7 | 65.6 units on a scale STANDARD_DEVIATION 48.1 | 60.3 units on a scale STANDARD_DEVIATION 48.9 |
| Preoperative Short Form Health Survey (SF-36 subscale) Social | 75.0 units on a scale STANDARD_DEVIATION 27.3 | 84.1 units on a scale STANDARD_DEVIATION 23.9 | 79.5 units on a scale STANDARD_DEVIATION 25.6 |
| Primary diagnosis Diverticulitis | 13 Participants | 19 Participants | 32 Participants |
| Primary diagnosis Irritable Bowel Disease | 3 Participants | 2 Participants | 5 Participants |
| Primary diagnosis Malignancy | 24 Participants | 21 Participants | 45 Participants |
| Primary diagnosis Other | 4 Participants | 4 Participants | 8 Participants |
| Procedure Type Lower Pelvic Anastomosis | 9 Participants | 13 Participants | 22 Participants |
| Procedure Type Partial Colectomy | 35 Participants | 33 Participants | 68 Participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 51 Participants |
| Surgical approach Laparoscopic | 2 Participants | 3 Participants | 5 Participants |
| Surgical approach Open | 6 Participants | 8 Participants | 14 Participants |
| Surgical approach Robotic | 36 Participants | 35 Participants | 71 Participants |
| Tobacco Use | 4 Participants | 8 Participants | 12 Participants |
| Wound class II, clean contaminated | 43 Participants | 45 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 48 |
| serious Total, serious adverse events | 0 / 50 | 0 / 48 |
Outcome results
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.
Time frame: Post-operative day 0
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Postoperative Numerical Pain Score-Day 0 | 3.9 units on a scale | Standard Deviation 2 |
| Continuous Epidural Analgesia (CEA) | Postoperative Numerical Pain Score-Day 0 | 2.6 units on a scale | Standard Deviation 1.7 |
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.
Time frame: Post-operative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Postoperative Numerical Pain Score-Day 1 | 3.2 units on a scale | Standard Deviation 1.8 |
| Continuous Epidural Analgesia (CEA) | Postoperative Numerical Pain Score-Day 1 | 2.6 units on a scale | Standard Deviation 1.9 |
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.
Time frame: Post-operative day 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Postoperative Numerical Pain Score-Day 2 | 2.6 units on a scale | Standard Deviation 1.7 |
| Continuous Epidural Analgesia (CEA) | Postoperative Numerical Pain Score-Day 2 | 2.1 units on a scale | Standard Deviation 1.7 |
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.
Time frame: Post-operative day 3
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Postoperative Numerical Pain Score-Day 3 | 2.9 units on a scale | Standard Deviation 1.9 |
| Continuous Epidural Analgesia (CEA) | Postoperative Numerical Pain Score-Day 3 | 2.7 units on a scale | Standard Deviation 1.9 |
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.
Time frame: Post-operative day 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Postoperative Numerical Pain Score-Day 4 | 3.1 units on a scale | Standard Deviation 2.1 |
| Continuous Epidural Analgesia (CEA) | Postoperative Numerical Pain Score-Day 4 | 2.7 units on a scale | Standard Deviation 1.8 |
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.
Time frame: After surgery in the post-anesthesia care unit
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU) | 3.5 units on a scale | Standard Deviation 2.8 |
| Continuous Epidural Analgesia (CEA) | Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU) | 2.3 units on a scale | Standard Deviation 2.5 |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Patient Use of Supplemental Narcotic Analgesia Day 0 | 20.5 morphine equivalents |
| Continuous Epidural Analgesia (CEA) | Patient Use of Supplemental Narcotic Analgesia Day 0 | 11.0 morphine equivalents |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Patient Use of Supplemental Narcotic Analgesia Day 1 | 29 Morphine equivalents |
| Continuous Epidural Analgesia (CEA) | Patient Use of Supplemental Narcotic Analgesia Day 1 | 23 Morphine equivalents |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Patient Use of Supplemental Narcotic Analgesia Day 2 | 22.4 morphine equivalents |
| Continuous Epidural Analgesia (CEA) | Patient Use of Supplemental Narcotic Analgesia Day 2 | 21.2 morphine equivalents |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Patient Use of Supplemental Narcotic Analgesia Day 3 | 17.4 morphine equivalents |
| Continuous Epidural Analgesia (CEA) | Patient Use of Supplemental Narcotic Analgesia Day 3 | 16.0 morphine equivalents |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Preperitoneal Analgesia (CPA) | Patient Use of Supplemental Narcotic Analgesia Day 4 | 6.9 morphine equivalents |
| Continuous Epidural Analgesia (CEA) | Patient Use of Supplemental Narcotic Analgesia Day 4 | 9.2 morphine equivalents |