NCT03378804

Brief Summary

The aim of the study is to compare programmed intermittent bolus application and continuous epidural infusion with regard to additionally applied patient-controlled volume of local anesthesia and quality of analgesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

October 6, 2017

Last Update Submit

August 22, 2018

Conditions

Pain, Postoperative

Keywords

PCEAPIEBepidural analgesia

Outcome Measures

Primary Outcomes (1)

  • Number of additional patient-controlled bolus of ropivacaine 0.2% (consumption in ml)

    The patient-controlled bolus function is programmed with 4ml at a lock-out interval of 30min. The number of additional patient-controlled boli will be read off the epidural pump at 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day

    Beginning of operation -6 pm on the second postoperative day

Secondary Outcomes (1)

  • quality of analgesia

    At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day

Other Outcomes (5)

  • Necessity of additional rescue medication

    Beginning of operation until 6 pm on the second postoperative day

  • Sensory blockade

    Beginning of operation -6 pm on the second postoperative day

  • Patient satisfaction with pain management

    At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day

  • +2 more other outcomes

Study Arms (2)

PIEB-PCEA

EXPERIMENTAL

Programmed intermittent epidural bolus (PIEB) application of ropivacaine 0.2% with patient-controlled epidural analgesia: The background rate is set at 6ml per hour. The patient-controlled bolus function is programmed with 4ml at a lock-out interval of 30min.

Procedure: Programmed intermittent epidural bolus application (PIEB)

CEI-PCEA

ACTIVE COMPARATOR

Continous epidural analgesia with patient-controlled analgesia using ropivacaine 0.2%: The background rate is set at 6 ml / h continuously. The patient-controlled bolus function is programmed in with 4ml at a lock-out interval of 30min.

Procedure: Continous epidural analgesia

Interventions

Programmed intermittent epidural bolus application (PIEB)PROCEDURE

Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.

PIEB-PCEA
Continous epidural analgesiaPROCEDURE
CEI-PCEA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Abdominal tumors in gynecology and general surgery
  • Enlightenment and written consent to the investigation

You may not qualify if:

  • refusal to participate
  • pregnancy and breast feeding period
  • general contraindications for thoracic epidural anesthesia (e.g. coagulation disorders, --anticoagulation according to the guidelines of DGAI)
  • Impossibility to place the epidural catheter correctly
  • Known allergy to the drugs used in the study
  • Lack of understanding how to use the patient-controlled system
  • postoperative follow-up respiratory assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philipps Universität Marburg

Marburg, 35037, Germany

Location

Related Publications (1)

  • Wiesmann T, Hoff L, Prien L, Torossian A, Eberhart L, Wulf H, Feldmann C. Programmed intermittent epidural bolus versus continuous epidural infusion for postoperative analgesia after major abdominal and gynecological cancer surgery: a randomized, triple-blinded clinical trial. BMC Anesthesiol. 2018 Oct 30;18(1):154. doi: 10.1186/s12871-018-0613-6.

    PMID: 30376810DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

October 6, 2017

First Posted

December 20, 2017

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 2, 2017

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)