Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery

Pain, Postoperative Clinical Trial

Official title:

Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Major Abdominal Surgery: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254523
• Other study ID #: 2020-4832
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Analgesia, Epidural
• Pain, Postoperative

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)