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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04254523
Other study ID # 2020-4832
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 14, 2019
Est. completion date December 1, 2020

Study information

Verified date January 2021
Source CHU de Quebec-Universite Laval
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Epidural analgesia is an efficient way to relieve pain after major abdominal surgery. Two different protocols are used to provide analgesia: continuous epidural infusion (CEI) and programmed intermittent boluses (PIEB). CEI consists in the delivery of a continuous administration of the intended hourly dose. PIEB consists in the administration of sequential high pressure boluses of the intended dose. Although some studies in the postoperative setting have observed that PIEB reduces the total dose needed to ensure adequate pain control, the clinical value of this finding is still uncertain. Moreover, nursing and medical interventions to the epidural infusion rates are frequently needed in the first 48 postoperative hours to optimize the provision of analgesia. These interventions add to the already important nursing workload associated with major abdominal surgery, and are correlated with suboptimal analgesia for the patient. This randomized controlled trial aims to compare the effect of epidural PIEB on the workload as a reflection of adequate analgesia compared to the standard CEI protocol in use. The investigators hypothesize that the use of PIEB decreases the number of interventions needed to obtain adequate analgesia.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date December 1, 2020
Est. primary completion date May 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (18 years and older) - Major abdominal surgery in an elective setting - Thoracic epidural (between T7 and T12) Exclusion Criteria: - Contraindication to bupivacaine - Contraindication to morphine - Decision to keep the patient intubated and sedated at the end of the surgery - Chronic opioid use (> 3 months) - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Programmed intermittent epidural bolus (PIEB) of bupicavaine
Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia. Standardized patient-controlled epidural boluses are available as top-ups.
Continuous epidural infusion (CEI) of bupivacaine
A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia. Standardized patient-controlled epidural boluses are available as top-ups.
Continuous epidural infusion (CEI) of morphine
A morphine infusion (0,1mg/ml) is administered in both groups at a prescribed rate. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia.

Locations

Country Name City State
Canada CHU de Quebec-Universite Laval Quebec

Sponsors (1)

Lead Sponsor Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of epidural infusion adjustments Number of epidural infusion adjustments by the nursing team (based on the usual protocol of our institution) will be recorded. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Quality of analgesia Pain is measured using the numeric rating scale (NRS : 0-10, 10 being the worst possible pain). 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Additional analgesia Prescribed additional analgesia (IV/PO/S/C opioids or other) administered to the patient while epidural analgesia is still provided. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Incidence of hypotension Documented by medical records review (vitals, medication received, temporary interruption of the local anesthetic epidural infusion, IV fluids, etc.). 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Vasopressor use The use of vasopressor is documented by review of the medical records. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Total epidural dose of local anesthetic administered Total epidural dose of local anesthetic administered (including additional boluses ordered by the anesthesiologist and PCEA). 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Total epidural dose of opioid administered Total epidural dose of opioid administered. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Number of patient-controlled epidural analgesia (PCEA) administered/refused Number of PCEA administered/refused. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary ICU length of stay ICU length of stay From the admission to the ICU until the end of the ICU stay (or until the patient has met ICU discharge criteria).
Secondary Time to postoperative mobilization Time to postoperative mobilization as defined as a patient who can tolerate standing without symptoms that limit the mobilization. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Incidence of Nausea and vomiting Nausea and vomiting 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Incidence of Pruritus Pruritus 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Motor blockade Bromage score is used to monitor motor blockade. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
Secondary Incidence of epidural removal Incidence of epidural catheter intentionally or unintentionally withdrawn. 48 hours after reaching the discharge criteria from the post-anesthesia care unit (or until the beginning of the epidural weaning period, if started in less than 48 hours)
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