PIEB-PCEA vs CEI-PCEA for Abdominal Oncological Surgery. A Randomized Prospective Clinical Trial

Pain, Postoperative Clinical Trial

— PIEB  

Official title:

Randomized Comparison of Two Application Procedures: Programmed Intermittent Epidural Bolus in Patient-controlled Epidural Analgesia (PCEA) Versus Continous PCEA in Abdominal Oncological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378804
• Other study ID #: nklnk
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 2, 2017

Study information

• Verified date: August 2018
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Usually, patient controlled epidural analgesia (PCEA) is performed with a constant background infusion and patient-controlled bolus applications. An alternative approach is to give boluses at a regular rate for basic medication, instead of the continuous background infusion, maintaining the same amount of medication delivered per hour, (Programmed Intermittent Epidural Bolus injection; PIEB). In both cases, the patient has the option to trigger additional boluses. PIEB has been applied successfully in pain relief for lumbar epidural anesthesia in obstetrics, with better quality of analgesia and less total volume of local anesthetic required. It is assumed that the higher pressure in the epidural space with bolus injection results in a better and more uniform spread of the local anesthetic. In this study the PIEB-mode will be applied in major gynecological and abdominal surgery. In order to address the possibility that the different types of surgery result in different degrees of postoperative pain, the patients are stratified in three groups and randomized within these groups (Wertheim, Whipple, major colon surgery).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Abdominal tumors in gynecology and general surgery

• Enlightenment and written consent to the investigation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Programmed intermittent epidural bolus application (PIEB)
Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.
• Continous epidural analgesia

Locations

Country	Name	City	State
Germany	Philipps Universität Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Necessity of additional rescue medication	Piritramid 7,5mg	Beginning of operation until 6 pm on the second postoperative day
Other	Sensory blockade	Sensory blockade is measured with a tiptherm, motor blockade on the Bromage scale 0-3 (0= no blockade; 1=Inability to lift legs stretched; 2=Inability to bend knees, 3=Inability to move feet )	Beginning of operation -6 pm on the second postoperative day
Other	Patient satisfaction with pain management	Measured on a visual analog scale of 0-10	At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
Other	first defecation/flatus	dichotomous yes/no	after the operation till the end of hospital stay (max 20days)
Other	motor blockade	motor blockade is measured on the Bromage scale 0-3.	Beginning of operation -6 pm on the second postoperative day
Primary	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	quality of analgesia	Measured on a visual analog scale of 0-10 (0="no pain" ; 10= "worst imaginable pain"	At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day