Effects of; Anesthesia, Spinal and Epidural, in PregnancyNCT04202887
The Effect of Low-Dose vs High-Dose Epidural Fentanyl on Gastric Emptying - A Prospective Double-Blinded Randomized Controlled Trial
A study testing Low Dose Fentanyl, High Dose Fentanyl and Gastric Ultrasonography in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy and Aspiration, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This study investigates the effect of epidural fentanyl on gastric emptying in non-fasted laboring women. Half the women will be randomized to receive low-dose epidural fentanyl (<100 mcg), and half will be randomized to receive high-dose epidural fentanyl (≥100 mcg). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, Aspiration
- What is being tested?
- Low Dose Fentanyl, High Dose Fentanyl and Gastric Ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jul 2020to 30 Oct 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboring women ≥18 years of age
- ≥37 weeks gestation
- Singleton pregnancy with cephalad fetus
- Cervical dilatation less than 5cm
- Request for epidural analgesia
Who cannot join
- Contraindications to neuraxial analgesia
- Chronic opioid consumption
- Increased risk of emergency cesarean delivery - Trial of labor after cesarean delivery (TOLAC), twin pregnancy, non-reassuring fetal heart rate (NRFHR), dysfunctional labor, estimated fetal weight>4000g, body mass index (BMI) ≥ 40kg/m2.
- Increased risk of aspiration - Disorders of the upper gastrointestinal tract (severe gastro-esophageal reflux, history of bariatric surgery), neurological and endocrine disorders associated with gastroparesis (such as multiple sclerosis, diabetes with autonomic neuropathy)
- BMI > 40kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effect of epidural fentanyl on gastric emptying in non-fasted laboring women. Half the women will be randomized to receive low-dose epidural fentanyl (<100 mcg), and half will be randomized to receive high-dose epidural fentanyl (≥100 mcg). Gastric content will be measured by ultrasonography two hours after epidural placement and compared between the groups.
Read the detailed description
Laboring women are known to be at increased risk of pulmonary aspiration in the event of general anesthesia, due to reduced lower esophageal sphincter pressure and delayed gastric emptying. Reduction in the rate of general anesthesia for cesarean delivery, improvements in airway management and premedication to improve gastric motility and increase gastric pH have greatly reduced the risk of aspiration in laboring women. This has raised questions regarding the need for restrictive fasting policies during labor, and more liberal food policies have become widespread in certain countries and birthing centers. In light of this, it is crucial to elucidate and limit any factors that may increase a woman's risk for aspiration.
Epidural opioids are usually added to the initial epidural bolus and the maintenance infusion, due to associated reduced local anesthetic dose requirements, while improving sensory block and decreasing motor block. However, systemic opioids are known to reduce gastric emptying. The effect of epidural fentanyl on gastric emptying has been investigated previously in various doses using the paracetamol absorption test. In several of these prior studies, epidural fentanyl administered in high doses (above the cut-off value of 100mcg) - either by bolus or infusion was associated with delayed gastric emptying, with no such effect with doses below this 100 mcg threshold. These studies were performed on fasting laboring women only. In addition, the paracetamol absorption test has been widely replaced by gastric ultrasonography to directly assess gastric contents by measuring the Cross-Sectional Area (CSA) of the antrum, and its feasibility has been demonstrated in laboring women.
The aim of our study is to assess the effect of high versus low dose epidural fentanyl on gastric emptying in non-fasted laboring women, using gastric ultrasonography.
Laboring women who consent to participate will be randomized to receive either high dose or low dose fentanyl in the epidural solution. A gastric ultrasound will be performed at the time of epidural placement (baseline) and two hours after the first measurement and will be compared between the two groups. Oral intake will be recorded as well in the 8 hours preceding epidural placement and between ultrasound measurements.
- Being tested
- Low Dose Fentanyl, High Dose Fentanyl, Gastric Ultrasonography
- Keywords
- Anesthesia, Aspiration, Epidural opioids, Gastric ultrasound, Gastric emptying, Labor fasting guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose FentanylDrug
10ml bolus: bupivacaine 0.1% + 25mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 1mcg/ml
High Dose FentanylDrug
10ml bolus: bupivacaine 0.1% + 100mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 2mcg/ml
Gastric UltrasonographyDevice
The Gastric US will be performed using a portable device with an abdominal probe by the same operator (EF) for all women. The Cross Sectional Area (CSA) of the antrum will be measured in the supine position with the head elevated 45 degrees. CSA will be calculated using the formula (AP x CC x pi)/4, where AC is the anterio-posterior diameter and CC the cranio-caudal diameter. Three consecutive measurements will be performed and the average of the three will be used as the final data. The cutoff used to define a "full stomach" will be a CSA above 381 mm2, which has been validated in previous studies on laboring woman. Gastric US will be performed immediately after verification of effective epidural analgesia (T0) and intrapartum, two hours after the first measurement (T2h), corresponding to a cumulative dose of 37-97mcg fentanyl in Group LF and 124-240mcg fentanyl in Group HF.
| Study group | Role | What they receive |
|---|---|---|
| Low Fentanyl (LF) | Active comparator | fentanyl cumulative dose below 100mcg Receives: Drug: Low Dose Fentanyl; Device: Gastric Ultrasonography |
| High Fentanyl (HF) | Active comparator | fentanyl cumulative dose above 100mcg Receives: Drug: High Dose Fentanyl; Device: Gastric Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSA two hours after epidural placement
CSA measured by ultrasonography two hours after first measurement (at T2h) in "High dose Fentanyl" (HF) versus "Low dose Fentanyl" (LF)
Measured: 2 hours after epidural placement
Secondary outcomes (1)
Change in CSA from baseline in HF versus LF
Comparison of CSA at 2h for subgroups - LF/Empty vs. HF/Empty and of LF/Full vs. HF/Full , and comparison of CSA-baseline vs. CSA-2h for each subgroup.
Measured: Baseline and at 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start30 Jul 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of; Anesthesia, Spinal and Epidural, in PregnancyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded randomized controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Idit Matot, M.D., Study chair, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202887
- Sponsor's protocol ID
- TASMC-19-CW-004019-CTIL
- Status last verified
- Oct 2020
- First submitted
- 17 Jul 2019
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiszer E, Aptekman B, Baar Y, Weiniger CF. The effect of high-dose versus low-dose epidural fentanyl on gastric emptying in nonfasted parturients: A double-blinded randomised controlled trial. Eur J Anaesthesiol. 2022 Jan 1;39(1):50-57. doi: 10.1097/EJA.0000000000001514.
PubMed 33852498
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-Dose vs High-Dose Epidural Fentanyl on Gastric Emptying - A Prospective Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04202887
- Acronym / sponsor ID
- TASMC-19-CW-004019-CTIL
- Keywords
- Anesthesia, Aspiration, Epidural opioids, Gastric ultrasound, Gastric emptying, Labor fasting guidelines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 18 Dec 2019 (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.
This study investigates the effect of epidural fentanyl on gastric emptying in non-fasted laboring women. Half the women will be randomized to receive low-dose epidural fentanyl (<100 mcg), and half will be randomized to receive high-dose epidural fentanyl (≥100 mcg). Gastric content will be measured by ultrasonography two hours after epidural placement and compared between the groups.
Detailed description
Laboring women are known to be at increased risk of pulmonary aspiration in the event of general anesthesia, due to reduced lower esophageal sphincter pressure and delayed gastric emptying. Reduction in the rate of general anesthesia for cesarean delivery, improvements in airway management and premedication to improve gastric motility and increase gastric pH have greatly reduced the risk of aspiration in laboring women. This has raised questions regarding the need for restrictive fasting policies during labor, and more liberal food policies have become widespread in certain countries and birthing centers. In light of this, it is crucial to elucidate and limit any factors that may increase a woman's risk for aspiration.
Epidural opioids are usually added to the initial epidural bolus and the maintenance infusion, due to associated reduced local anesthetic dose requirements, while improving sensory block and decreasing motor block. However, systemic opioids are known to reduce gastric emptying. The effect of epidural fentanyl on gastric emptying has been investigated previously in various doses using the paracetamol absorption test. In several of these prior studies, epidural fentanyl administered in high doses (above the cut-off value of 100mcg) - either by bolus or infusion was associated with delayed gastric emptying, with no such effect with doses below this 100 mcg threshold. These studies were performed on fasting laboring women only. In addition, the paracetamol absorption test has been widely replaced by gastric ultrasonography to directly assess gastric contents by measuring the Cross-Sectional Area (CSA) of the antrum, and its feasibility has been demonstrated in laboring women.
The aim of our study is to assess the effect of high versus low dose epidural fentanyl on gastric emptying in non-fasted laboring women, using gastric ultrasonography.
Laboring women who consent to participate will be randomized to receive either high dose or low dose fentanyl in the epidural solution. A gastric ultrasound will be performed at the time of epidural placement (baseline) and two hours after the first measurement and will be compared between the two groups. Oral intake will be recorded as well in the 8 hours preceding epidural placement and between ultrasound measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Low Fentanyl (LF) | Active comparator | Drug: Low Dose Fentanyl, Device: Gastric Ultrasonographyfentanyl cumulative dose below 100mcg |
| High Fentanyl (HF) | Active comparator | Drug: High Dose Fentanyl, Device: Gastric Ultrasonographyfentanyl cumulative dose above 100mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Laboring women ≥18 years of age
- ≥37 weeks gestation
- Singleton pregnancy with cephalad fetus
- Cervical dilatation less than 5cm
- Request for epidural analgesia
Key exclusion criteria (5 listed)
- Contraindications to neuraxial analgesia
- Chronic opioid consumption
- Increased risk of emergency cesarean delivery - Trial of labor after cesarean delivery (TOLAC), twin pregnancy, non-reassuring fetal heart rate (NRFHR), dysfunctional labor, estimated fetal weight>4000g, body mass index (BMI) ≥ 40kg/m2.
- Increased risk of aspiration - Disorders of the upper gastrointestinal tract (severe gastro-esophageal reflux, history of bariatric surgery), neurological and endocrine disorders associated with gastroparesis (such as multiple sclerosis, diabetes with autonomic neuropathy)
- BMI > 40kg/m2
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 |
|---|---|---|
| Low Dose Fentanyl10ml bolus: bupivacaine 0.1% + 25mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 1mcg/ml | Drug | Low Fentanyl (LF) |
| High Dose Fentanyl10ml bolus: bupivacaine 0.1% + 100mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 2mcg/ml | Drug | High Fentanyl (HF) |
| Gastric UltrasonographyThe Gastric US will be performed using a portable device with an abdominal probe by the same operator (EF) for all women. The Cross Sectional Area (CSA) of the antrum will be measured in the supine position with the head elevated 45 degrees. CSA will be calculated using the formula (AP x CC x pi)/4, where AC is the anterio-posterior diameter and CC the cranio-caudal diameter. Three consecutive measurements will be performed and the average of the three will be used as the final data. The cutoff used to define a "full stomach" will be a CSA above 381 mm2, which has been validated in previous studies on laboring woman. Gastric US will be performed immediately after verification of effective epidural analgesia (T0) and intrapartum, two hours after the first measurement (T2h), corresponding to a cumulative dose of 37-97mcg fentanyl in Group LF and 124-240mcg fentanyl in Group HF. | Device | High Fentanyl (HF), Low Fentanyl (LF) |
Primary outcome
CSA two hours after epidural placement
Time frame: 2 hours after epidural placement
CSA measured by ultrasonography two hours after first measurement (at T2h) in "High dose Fentanyl" (HF) versus "Low dose Fentanyl" (LF)
1 secondary outcome
Change in CSA from baseline in HF versus LF
Time frame: Baseline and at 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Derived from this study: PubMed 33852498Fiszer E, Aptekman B, Baar Y, Weiniger CF. The effect of high-dose versus low-dose epidural fentanyl on gastric emptying in nonfasted parturients: A double-blinded randomised controlled trial. Eur J Anaesthesiol. 2022 Jan 1;39(1):50-57. doi: 10.1097/EJA.0000000000001514.
- 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.
Idit Matot, M.D. study chair
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Fentanyl, High Dose Fentanyl and Gastric Ultrasonography in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy and Aspiration, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. 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 Israel. 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?
Results are not available in the source record.
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?
CSA two hours after epidural placement (time frame: 2 hours after epidural placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202887, which also lists 1 linked publication.
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 Oct 2020.