Analgesia, EpiduralNCT04254523
Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Abdominal Surgery
A study testing Programmed intermittent epidural bolus (PIEB) of bupicavaine, Continuous epidural infusion (CEI) of bupivacaine and Continuous epidural infusion (CEI) of morphine in people with Analgesia, Epidural and Pain, Postoperative, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Epidural, Pain, Postoperative
- What is being tested?
- Programmed intermittent epidural bolus (PIEB) of bupicavaine, Continuous epidural infusion (CEI) of bupivacaine and Continuous epidural infusion (CEI) of morphine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 14 Nov 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years and older)
- Major abdominal surgery in an elective setting
- Thoracic epidural (between T7 and T12)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Major Abdominal Surgery: a Randomized Clinical Trial
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.
- Conditions
- Analgesia, Epidural, Pain, Postoperative
- Being tested
- Programmed intermittent epidural bolus (PIEB) of bupicavaine, Continuous epidural infusion (CEI) of bupivacaine, Continuous epidural infusion (CEI) of morphine
- Keywords
- Anesthesia, Epidural, Postoperative Period, Analgesia, Patient-Controlled
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed intermittent epidural bolus (PIEB) of bupicavaineDevice
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 bupivacaineDevice
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 morphineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Programmed intermittent epidural bolus (PIEB) | Experimental | Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour. Receives: Device: Programmed intermittent epidural bolus (PIEB) of bupicavaine; Device: Continuous epidural infusion (CEI) of morphine |
| Continuous epidural infusion (CEI) | Experimental | A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate in milliliters per hour. Receives: Device: Continuous epidural infusion (CEI) of bupivacaine; Device: Continuous epidural infusion (CEI) of morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (13)
Quality of analgesia
Pain is measured using the numeric rating scale (NRS : 0-10, 10 being the worst possible pain).
Measured: 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)
Additional analgesia
Prescribed additional analgesia (IV/PO/S/C opioids or other) administered to the patient while epidural analgesia is still provided.
Measured: 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)
Incidence of hypotension
Documented by medical records review (vitals, medication received, temporary interruption of the local anesthetic epidural infusion, IV fluids, etc.).
Measured: 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)
Vasopressor use
The use of vasopressor is documented by review of the medical records.
Measured: 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)
Total epidural dose of local anesthetic administered
Total epidural dose of local anesthetic administered (including additional boluses ordered by the anesthesiologist and PCEA).
Measured: 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)
Total epidural dose of opioid administered
Total epidural dose of opioid administered.
Measured: 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)
Number of patient-controlled epidural analgesia (PCEA) administered/refused
Number of PCEA administered/refused.
Measured: 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)
ICU length of stay
ICU length of stay
Measured: From the admission to the ICU until the end of the ICU stay (or until the patient has met ICU discharge criteria).
Time to postoperative mobilization
Time to postoperative mobilization as defined as a patient who can tolerate standing without symptoms that limit the mobilization.
Measured: 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)
Incidence of Nausea and vomiting
Nausea and vomiting
Measured: 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)
Incidence of Pruritus
Pruritus
Measured: 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)
Motor blockade
Bromage score is used to monitor motor blockade.
Measured: 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)
Incidence of epidural removal
Incidence of epidural catheter intentionally or unintentionally withdrawn.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start14 Nov 2019
- Primary completion23 May 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Breton, CHU de Quebec-Universite Laval
- Investigators
- Esther Breton, MD, FRCPC, Principal investigator, CHU de Québec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254523
- Sponsor's protocol ID
- 2020-4832
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Bolus Versus Continuous Infusion for Epidural Analgesia in Major Abdominal Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04254523
- Acronym / sponsor ID
- 2020-4832
- Conditions
- Analgesia, Epidural, Pain, Postoperative
- Keywords
- Anesthesia, Epidural, Postoperative Period, Analgesia, Patient-Controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 23 May 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programmed intermittent epidural bolus (PIEB) | Experimental | Device: Programmed intermittent epidural bolus (PIEB) of bupicavaine, Device: Continuous epidural infusion (CEI) of morphineProgrammed intermittent epidural boluses of bupivacaine 0,1% are administered every hour. |
| Continuous epidural infusion (CEI) | Experimental | Device: Continuous epidural infusion (CEI) of bupivacaine, Device: Continuous epidural infusion (CEI) of morphineA continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate in milliliters per hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 years and older)
- Major abdominal surgery in an elective setting
- Thoracic epidural (between T7 and T12)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmed intermittent epidural bolus (PIEB) of bupicavaineProgrammed 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. | Device | Programmed intermittent epidural bolus (PIEB) |
| Continuous epidural infusion (CEI) of bupivacaineA 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. | Device | Continuous epidural infusion (CEI) |
| Continuous epidural infusion (CEI) of morphineA 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. | Device | Continuous epidural infusion (CEI), Programmed intermittent epidural bolus (PIEB) |
Primary outcome
Number of epidural infusion adjustments
Time frame: 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)
Number of epidural infusion adjustments by the nursing team (based on the usual protocol of our institution) will be recorded.
13 secondary outcomes
Quality of analgesia
Time frame: 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)
Additional analgesia
Time frame: 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)
Incidence of hypotension
Time frame: 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)
Vasopressor use
Time frame: 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)
Total epidural dose of local anesthetic administered
Time frame: 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)
Total epidural dose of opioid administered
Time frame: 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)
Number of patient-controlled epidural analgesia (PCEA) administered/refused
Time frame: 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)
ICU length of stay
Time frame: From the admission to the ICU until the end of the ICU stay (or until the patient has met ICU discharge criteria).
Time to postoperative mobilization
Time frame: 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)
Incidence of Nausea and vomiting
Time frame: 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)
Incidence of Pruritus
Time frame: 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)
Motor blockade
Time frame: 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)
Incidence of epidural removal
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Breton, MD, FRCPC principal investigator
CHU de Québec-Universite Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed intermittent epidural bolus (PIEB) of bupicavaine, Continuous epidural infusion (CEI) of bupivacaine and Continuous epidural infusion (CEI) of morphine in people with Analgesia, Epidural and Pain, Postoperative, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of epidural infusion adjustments (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.