Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02423876
Other study ID # UW14030
Secondary ID NCI-2015-0039520
Status Completed
Phase Phase 3
First received
Last updated
Start date March 17, 2015
Est. completion date January 3, 2022

Study information

Verified date August 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized clinical trial studies epidural anesthesia within an enhanced recovery pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and stops the feeling of pain. It stays in place for several days after surgery and may be helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of specific steps used before, during, and after surgery by health care providers to care for patients after surgery. ERPs include patient education, not using laxatives before surgery, increasing activity after surgery, and scheduled use of medications for pain and nausea. Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing gynecologic surgery.


Description:

PRIMARY OBJECTIVES: I. Mean postoperative pain score for the first 24 hours post-operatively, (measured by the Numeric Rating Scale [NRS], which rates pain on a 1-10 scale, collected routinely on the post-operative floor) will be compared between the epidural and no-epidural groups. SECONDARY OBJECTIVES: I. Total opioid use measured in oral morphine equivalents for the first two days post-surgery. II. Length of hospital stay (measured in hours from admission to time of discharge order placement). III. Post-operative antiemetic use and number of recorded episodes of emesis. IV. Return of bowel function (measured in hours from completion of surgery to passage of flatus). V. Subject satisfaction at the 4 week post-operative visit (as measured by two pain satisfaction questions taken from the Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS] survey). VI. Post-operative complications (urinary tract infections [UTIs], thromboembolic events, pneumonia, blood transfusion, myocardial infarction, falls). VII. Readmission rate. VIII. Epidural discontinuation rates prior to planned removal (in epidural group only). IX. Stress and inflammation serum and saliva markers at baseline and the first day after surgery, as well as at their postoperative visit. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo epidural placement in the First Day Surgery pre-operative area or similar areas suitable for insertion of epidural catheters. In the post-operative anesthesia care unit, patients may receive medication via the epidural on an as needed basis, as determined by the anesthesia team. Dosing and rate of standardized medication will be managed by the anesthesia team until the epidural is removed. Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain. ARM II: Patients complete the ERP comprising increased activity, dietary restrictions, fluid balance, as well as anti-nausea, anti-inflammatory and pain medications at specific times. Patients will have access to additional pain medications as needed to control their pain.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date January 3, 2022
Est. primary completion date January 3, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing gynecologic surgery via midline vertical laparotomy at University of Wisconsin Hospital and Clinics (UWHC) - Patients must be English speaking - Patients must have the ability to understand visual and verbal pain scales - Patients must be eligible for epidural placement Exclusion Criteria: - Known allergy to local anesthetics - Known history of chronic pain disorders and/or chronic opioid use defined as > 10 mg of oral (PO) morphine or equivalent used daily for at least 30 days prior to enrollment - Patient is a prisoner or incarcerated - Significant liver disease that would inhibit prescription of opioids - Significant kidney disease that would inhibit administration of gabapentin - Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists - Patient is pregnant - Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Epidural analgesia
Receive epidural placement. Standard epidural medications and dosage are as follows: 0.1% ropivicaine + 10 mcg/mL hydromorphone at 6 mL/hr continuous rate 3 mL/hr RN bolus, to be used as needed based on pain ratings 3 mL/30 minutes patient bolus, which is available on patient demand.
Other:
Intraoperative Complication Management and Prevention
Undergo ERP
Procedure:
Pain Therapy
Undergo ERP

Locations

Country Name City State
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS) Relative pain scores between the epidural and non-epidural group will be analyzed by calculating a two-sided 95% confidence interval on the difference in mean scores between the two groups and concluding non-inferiority if this lies entirely below 2 points (mean non-epidural pain score proven, within a 95% confidence limit, to be at most 2 points worse than mean pain score in the epidural group). NRS rates pain on a 1-10 scale, with 1 being no pain, and 10 being the worst pain imaginable. Up to 24 hours post-surgery
Secondary Average Daily Pain Score as Measured by Pain NRS Scores Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Up to 2 days following surgery
Secondary Difference in IL-2 Levels Between Pre-operative and Post-operative Values Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Baseline to up to day 1 post-surgery
Secondary Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only) Will be tabulated and presented for each group (where applicable). Up to post-operative day 14
Secondary Length of Hospital Stay (Hours) Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. From admission to time of discharge order placement
Secondary Length of Time Until Return of Bowel Function Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. From completion of surgery to passage of flatus (report in days)
Secondary Number of Recorded Episodes of Emesis Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Up to 5 days post-surgery
Secondary Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Scores range from 1 to 4, with higher scores indicating higher satisfaction. At 4 weeks post-operative visit
Secondary Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery) Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Up to 4 weeks post-surgery
Secondary Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls) # of events in each group will be reported Up to 6 weeks post-surgery
Secondary Readmission Rate Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Up to 6 weeks post-surgery
Secondary Total Opioid Use Measured in Oral Morphine Equivalents (mg) Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. Up to first 2 days post-surgery
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care