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

Trinity Health Michigan98 enrolled

Overview

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 * 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Postoperative Numerical Pain Score-Day 1

Time frame: Post-operative day 1

Postoperative Numerical Pain Score-Day 2

Time frame: Post-operative day 2

Postoperative Numerical Pain Score-Day 3

Time frame: Post-operative day 3

Postoperative Numerical Pain Score-Day 4

Time frame: 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".

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

Secondary Outcomes

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

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

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

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

Patient Use of Supplemental Narcotic Analgesia Day 0

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