Anesthesia; FunctionalPhase 4CESNCT03386630
Effects of Analgesics in Cesarean Section Elective
A Phase 4 study testing Hyperbaric bupivacaine+Sufentanil and Hyperbaric bupivacaine+Morphine in people with Anesthesia; Functional, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
Trial summary
Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section. It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- Hyperbaric bupivacaine+Sufentanil and Hyperbaric bupivacaine+Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 28 Mar 2018to 28 Jul 2019
- Phase
- Phase 4
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of at least 18 years.
- Patients at least 36 weeks gestation.
- Patients scheduled for non-urgent cesarean section.
- Patients classified in the physical state of the American Society of Anesthesiologists (ASA) as grade I-II, and without important fetal pathological conditions.
- Signature of informed consent that allows them to be part of the study.
Who cannot join
- Pregnant women who reject the spinal technique.
- Patients with contraindication to spinal anesthesia.
- Patients with ASA> II classification.
- Patients with multiple pregnancy.
- Patients with three or more previous cesareans,
- Patients with BMI greater than or equal to 40 kg / m2.
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- Language barrier.
- Patients with pre-eclampsia.
- Patients with a history of chronic pain.
- Patients with a history of psychiatric or drug abuse.
- Patients with allergy to any of the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section
Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section.
It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to decrease postoperative pain, but we try to check if one brings more benefit than the other.
- Conditions
- Anesthesia; Functional
- Being tested
- Hyperbaric bupivacaine+Sufentanil, Hyperbaric bupivacaine+Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric bupivacaine+SufentanilDrug
Also called Sufentanil
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg)
Hyperbaric bupivacaine+MorphineDrug
Also called Morphine
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg)
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric bupivacaine+Sufentanil | Experimental | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg) Receives: Drug: Hyperbaric bupivacaine+Sufentanil |
| Hyperbaric bupivacaine+morphine | Experimental | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg) Receives: Drug: Hyperbaric bupivacaine+Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine plus opioid: sufentanil or morphine, produces a longer time for the patient to administer a first analgesic bolus of intravenous morphine.
Measured: 3 days
Secondary outcomes (4)
Lower intravenous morphine consumption
Measured: 24 hours after surgery
Levels of minor pain verbal scales
The measure is based in EVA (Escala visual analógica del dolor) scale. EVA scale allows to measure the pain intensity that the patient describes with the maximum reproducibility among the observers.
- Mild pain if the patient scores the pain as less than 3.
- Moderate pain if the assessment is between 4 and 7.
- Severe pain if the assessment is equal to or greater than 8.
Measured: At 3, 6, 12 and 24 hours after surgery
Beginning of sitting and standing
Measured: At 48 hours after surgery
Mother´s side effects with respect to hemodynamic alteration, nausea, vomits, pruritus, tremor, urinary retention, sedation, respiratory depression, headaches, motor deficits, permanent sensory or autonomic deficits.
Measured: At intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start28 Mar 2018
- Primary completion30 Jun 2019
- Study completion28 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; FunctionalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial, without masking techniques, is proposed in pregnant women who are to undergo elective caesarean section by subarachnoid anesthesia with hyperbaric bupivacaine associated with sufentanil or morphine
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386630
- Sponsor's protocol ID
- FPS-CES-2017-01
- Acronym
- CES
- Status last verified
- Jan 2020
- First submitted
- 20 Nov 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT03386630
- Acronym / sponsor ID
- CES / FPS-CES-2017-01
- Conditions
- Anesthesia; Functional
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 28 Jul 2019 (actual)
- First posted
- 29 Dec 2017 (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.
Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section.
It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to decrease postoperative pain, but we try to check if one brings more benefit than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical trial, without masking techniques, is proposed in pregnant women who are to undergo elective caesarean section by subarachnoid anesthesia with hyperbaric bupivacaine associated with sufentanil or morphine
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric bupivacaine+Sufentanil | Experimental | Drug: Hyperbaric bupivacaine+SufentanilTo evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg) |
| Hyperbaric bupivacaine+morphine | Experimental | Drug: Hyperbaric bupivacaine+MorphineTo evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of at least 18 years.
- Patients at least 36 weeks gestation.
- Patients scheduled for non-urgent cesarean section.
- Patients classified in the physical state of the American Society of Anesthesiologists (ASA) as grade I-II, and without important fetal pathological conditions.
- Signature of informed consent that allows them to be part of the study.
Key exclusion criteria (11 listed)
- Pregnant women who reject the spinal technique.
- Patients with contraindication to spinal anesthesia.
- Patients with ASA> II classification.
- Patients with multiple pregnancy.
- Patients with three or more previous cesareans,
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 |
|---|---|---|
| Hyperbaric bupivacaine+SufentanilAlso: SufentanilTo evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg) | Drug | Hyperbaric bupivacaine+Sufentanil |
| Hyperbaric bupivacaine+MorphineAlso: MorphineTo evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg) | Drug | Hyperbaric bupivacaine+morphine |
Primary outcome
To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.
Time frame: 3 days
To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine plus opioid: sufentanil or morphine, produces a longer time for the patient to administer a first analgesic bolus of intravenous morphine.
4 secondary outcomes
Lower intravenous morphine consumption
Time frame: 24 hours after surgery
Levels of minor pain verbal scales
Time frame: At 3, 6, 12 and 24 hours after surgery
Beginning of sitting and standing
Time frame: At 48 hours after surgery
Mother´s side effects with respect to hemodynamic alteration, nausea, vomits, pruritus, tremor, urinary retention, sedation, respiratory depression, headaches, motor deficits, permanent sensory or autonomic deficits.
Time frame: At intraoperative
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 18 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric bupivacaine+Sufentanil and Hyperbaric bupivacaine+Morphine in people with Anesthesia; Functional, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
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 11 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 18 Jan 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section. (time frame: 3 days). 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 18 Jan 2020.