Randomized-controlled pilot trial to compare continuous wound infiltration with local anesthetics via elastomer pump versus epidural analgesia following elective upper abdominal surgery via midline laparotomy

Not Applicable

• Conditions: R52; postoperative pain management; Pain, not elsewhere classified

• Registration Number: DRKS00008023
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Study Completion: 2017-01-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Elective upper abdominal surgery via a midline-laparotomy
- Indication for epidural analgesia
- Age = 18 years
- Written informed consent
- Ability of subject to understand the nature and consequences of the clinical trial

Exclusion Criteria

- Chronic pain and/or regular consumption of opioid analgesics
- Contraindication for thoracic epidural analgesia or epifascial continuous wound infiltration
- Inability to walk unaided and without adjuvants
- Planned stoma placement
- Hypersensitivity or allergy to one or more of the analgesic medications used in the trial
- Pregnancy or breast-feeding
- Participation in another intervention-trial with interference of intervention and outcome of this study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Feasibility of assessing post-operative patient mobility with a pedometer<br>2. Feasibility of patient recruitment in the planned time frame<br>3. Evaluation of the comprehensive complication index (CCI) by examining the overall postoperative morbidity of patients in the study<br>4. Pain scores at rest and on movement 48 and 72 hours post-operatively according to the numeric rating scale (NRS)<br>5. Total amount of opioids administered during 0–24, 24–48 and 48-72 hours post-operatively<br>6. Time to first flatus/bowel movement<br>7. Body weight<br>8. Rate of treatment failure, defined as the need for the use of an intravenous patient-controlled analgesia PCA system<br>9. Rate of catheter-related complication<br>10. Rate of surgical side infection according to the definition of the Centre for Disease Control and Prevention (CDC)<br>11. Days of catheter-therapy <br>12. Length of hospital stay<br>13. Rate of serious adverse events (SAEs) in both groups.