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

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 - PAINLESS-Pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00008023

Enrollment

Registered

2015-12-04

Start date

2015-10-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain management R52

Interventions

Group 1: Pain management after upper abdominal surgery with epifascial placement of a continuous wound infiltration catheter (On-Q® PainBuster®, Vertrieb B. Braun, Melsungen) with Ropivacain 0.2% isob

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Germany

Contacts

Public ContactRosa Klotz

Abteilung für Allgemein,- Viszeral,- und Transplantationschirurgie, Chirurgische Universitätsklinik Heidelberg 69120 Heidelberg Germany

rosa.klotz@med.uni-heidelberg.de06221/56 34726

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026