Philipps Universität Marburg
Marburg, 35037, Germany
NCT Number: NCT03378804
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Marburg, 35037, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.
Time frame: Beginning of operation -6 pm on the second postoperative day
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
Time frame: At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
Measured on a visual analog scale of 0-10 (0="no pain" ; 10= "worst imaginable pain"
Time frame: Beginning of operation until 6 pm on the second postoperative day
Piritramid 7,5mg
Time frame: Beginning of operation -6 pm on the second postoperative day
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 )
Time frame: At 6 pm on the day of surgery, 6 pm on the 1st day and 6 pm on the 2nd day
Measured on a visual analog scale of 0-10
Time frame: after the operation till the end of hospital stay (max 20days)
dichotomous yes/no
Time frame: Beginning of operation -6 pm on the second postoperative day
motor blockade is measured on the Bromage scale 0-3.
Philipps University Marburg
Other
Randomized Comparison of Two Application Procedures: Programmed Intermittent Epidural Bolus in Patient-controlled Epidural Analgesia (PCEA) Versus Continous PCEA in Abdominal Oncological Surgery
Acronym: PIEB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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