Trial Outcomes & Findings for Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery (NCT NCT01552226)

Last Updated: 2025-09-15

Results Overview

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".

Recruitment status

COMPLETED

Study phase

Target enrollment

98 participants

Primary outcome timeframe

Post-operative day 0

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Continuous Epidural Analgesia (CEA) Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Overall Study STARTED	50	48
Overall Study COMPLETED	46	44
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Continuous Epidural Analgesia (CEA) Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

The numbers are different due to the difference in number of respondents on some of the sub scales.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Preperitoneal Analgesia (CPA) n=46 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=44 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.	Total n=90 Participants Total of all reporting groups
Procedure Type Partial Colectomy	33 Participants n=46 Participants	35 Participants n=44 Participants	68 Participants n=90 Participants
Procedure Type Lower Pelvic Anastomosis	13 Participants n=46 Participants	9 Participants n=44 Participants	22 Participants n=90 Participants
Age, Continuous	59.4 years STANDARD_DEVIATION 12.2 • n=46 Participants	60.8 years STANDARD_DEVIATION 12.6 • n=44 Participants	60.1 years STANDARD_DEVIATION 12.4 • n=90 Participants
Sex: Female, Male Female	18 Participants n=46 Participants	21 Participants n=44 Participants	39 Participants n=90 Participants
Sex: Female, Male Male	28 Participants n=46 Participants	23 Participants n=44 Participants	51 Participants n=90 Participants
BMI	29.1 kg/m^2 STANDARD_DEVIATION 6.6 • n=46 Participants	29.6 kg/m^2 STANDARD_DEVIATION 5.9 • n=44 Participants	29.35 kg/m^2 STANDARD_DEVIATION 6.25 • n=90 Participants
Tobacco Use	8 Participants n=46 Participants	4 Participants n=44 Participants	12 Participants n=90 Participants
Narcotics use	4 Participants n=46 Participants	2 Participants n=44 Participants	6 Participants n=90 Participants
Diabetes	4 Participants n=46 Participants	3 Participants n=44 Participants	7 Participants n=90 Participants
Blood thinners	3 Participants n=46 Participants	3 Participants n=44 Participants	6 Participants n=90 Participants
Primary diagnosis Malignancy	21 Participants n=46 Participants	24 Participants n=44 Participants	45 Participants n=90 Participants
Primary diagnosis Diverticulitis	19 Participants n=46 Participants	13 Participants n=44 Participants	32 Participants n=90 Participants
Primary diagnosis Irritable Bowel Disease	2 Participants n=46 Participants	3 Participants n=44 Participants	5 Participants n=90 Participants
Primary diagnosis Other	4 Participants n=46 Participants	4 Participants n=44 Participants	8 Participants n=90 Participants
Surgical approach Open	8 Participants n=46 Participants	6 Participants n=44 Participants	14 Participants n=90 Participants
Surgical approach Laparoscopic	3 Participants n=46 Participants	2 Participants n=44 Participants	5 Participants n=90 Participants
Surgical approach Robotic	35 Participants n=46 Participants	36 Participants n=44 Participants	71 Participants n=90 Participants
Wound class II, clean contaminated	45 Participants n=46 Participants	43 Participants n=44 Participants	88 Participants n=90 Participants
Preoperative Short Form Health Survey (SF-36 subscale) Aggregate score	74.7 units on a scale STANDARD_DEVIATION 14.6 • n=44 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	67.0 units on a scale STANDARD_DEVIATION 17.9 • n=42 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	70.8 units on a scale STANDARD_DEVIATION 16.2 • n=86 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Physical functioning	83.3 units on a scale STANDARD_DEVIATION 21.4 • n=44 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	73.3 units on a scale STANDARD_DEVIATION 26.0 • n=41 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	78.3 units on a scale STANDARD_DEVIATION 23.7 • n=85 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Role limitations: physical health	65.6 units on a scale STANDARD_DEVIATION 48.1 • n=8 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	55.0 units on a scale STANDARD_DEVIATION 49.7 • n=10 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	60.3 units on a scale STANDARD_DEVIATION 48.9 • n=18 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Role limitations: emotional problems	75.0 units on a scale STANDARD_DEVIATION 50.0 • n=4 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	60.0 units on a scale STANDARD_DEVIATION 54.8 • n=5 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	67.5 units on a scale STANDARD_DEVIATION 52.4 • n=9 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Energy	61.8 units on a scale STANDARD_DEVIATION 17.0 • n=42 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	55.3 units on a scale STANDARD_DEVIATION 18.8 • n=41 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	58.5 units on a scale STANDARD_DEVIATION 17.9 • n=83 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Emotional	69.5 units on a scale STANDARD_DEVIATION 13.2 • n=42 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	64.6 units on a scale STANDARD_DEVIATION 19.0 • n=41 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	67.0 units on a scale STANDARD_DEVIATION 16.1 • n=83 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Social	84.1 units on a scale STANDARD_DEVIATION 23.9 • n=44 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	75.0 units on a scale STANDARD_DEVIATION 27.3 • n=42 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	79.5 units on a scale STANDARD_DEVIATION 25.6 • n=86 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) Pain	76.4 units on a scale STANDARD_DEVIATION 27.5 • n=43 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	74.1 units on a scale STANDARD_DEVIATION 23.4 • n=42 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	75.2 units on a scale STANDARD_DEVIATION 25.4 • n=85 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.
Preoperative Short Form Health Survey (SF-36 subscale) General health	70.7 units on a scale STANDARD_DEVIATION 19.1 • n=44 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	65.4 units on a scale STANDARD_DEVIATION 21.0 • n=42 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.	68.0 units on a scale STANDARD_DEVIATION 20.0 • n=86 Participants • The numbers are different due to the difference in number of respondents on some of the sub scales.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=45 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=44 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Postoperative Numerical Pain Score-Day 0	3.9 units on a scale Standard Deviation 2.0	2.6 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Post-operative day 1

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=46 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=44 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Postoperative Numerical Pain Score-Day 1	3.2 units on a scale Standard Deviation 1.8	2.6 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Post-operative day 2

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=45 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=43 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Postoperative Numerical Pain Score-Day 2	2.6 units on a scale Standard Deviation 1.7	2.1 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Post-operative day 3

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=37 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=39 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Postoperative Numerical Pain Score-Day 3	2.9 units on a scale Standard Deviation 1.9	2.7 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: Post-operative day 4

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=26 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=26 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Postoperative Numerical Pain Score-Day 4	3.1 units on a scale Standard Deviation 2.1	2.7 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=44 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=41 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Postoperative Numerical Pain Score (NPS)- Post-Anaesthesia Care Unit (PACU)	3.5 units on a scale Standard Deviation 2.8	2.3 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=45 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=44 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Patient Use of Supplemental Narcotic Analgesia Day 1	29 Morphine equivalents Interval 20.1 to 41.8	23 Morphine equivalents Interval 14.4 to 36.4

SECONDARY outcome

Timeframe: Post-operative day 2

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

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=43 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=43 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Patient Use of Supplemental Narcotic Analgesia Day 2	22.4 morphine equivalents Interval 14.2 to 35.1	21.2 morphine equivalents Interval 13.9 to 32.0

SECONDARY outcome

Timeframe: Post-operative day 3

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

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=34 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=37 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Patient Use of Supplemental Narcotic Analgesia Day 3	17.4 morphine equivalents Interval 10.4 to 28.6	16.0 morphine equivalents Interval 10.7 to 23.7

SECONDARY outcome

Timeframe: Post-operative day 4

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

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=29 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=29 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Patient Use of Supplemental Narcotic Analgesia Day 4	6.9 morphine equivalents Interval 3.7 to 12.3	9.2 morphine equivalents Interval 5.1 to 15.9

SECONDARY outcome

Timeframe: Post-operative day 0

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

Outcome measures

Outcome measures
Measure	Continuous Preperitoneal Analgesia (CPA) n=45 Participants Continuous Preperitoneal Analgesia for pain management Continuous Preperitoneal Analgesia: Preperitoneal catheter placed at the completion of surgery in the standard fashion.	Continuous Epidural Analgesia (CEA) n=44 Participants Continuous Epidural Analgesia for pain management Continuous Epidural Analgesia: Epidural catheter placed prior to the operation in the standard fashion.
Patient Use of Supplemental Narcotic Analgesia Day 0	20.5 morphine equivalents Interval 14.2 to 29.5	11.0 morphine equivalents Interval 7.1 to 16.6

Adverse Events

Continuous Preperitoneal Analgesia (CPA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous Epidural Analgesia (CEA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Cleary

St. Joseph Mercy Hospital Ann Arbor

Phone: 7347128150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place