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AnalgesiaPhase 2NCT06036797

Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

A Phase 2 study testing Hydromorphone, Sufentanil and Ropivacaine in people with Analgesia and Labor Pain, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural… Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Analgesia, Labor Pain
What is being tested?
Hydromorphone, Sufentanil and Ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
17 Sep 2023to 17 Oct 2023
Phase
Phase 2
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status II
  • a single fetus
  • competent to provide informed consent

Who cannot join

  • severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia
  • severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy
  • placenta previa

Trial locations and contacts

1 site in 1 country.

Na Li, MD contact

+862763490107

lina@hbfy.com

China1 site, 1 recruiting

  • Maternal and Child Health Hospital of Hubei Province

    Wuhan, Hubei, 430000

    Na Li, MD, +862763490107, lina@hbfy.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial

The purpose of this study is to compare the effects of three different doses of hydromorphone combined with ropivacaine and sufentanil combined with ropivacaine in epidural labor analgesia through prospective clinical trials, so as to explore whether hydromorphone combined with ropivacaine has advantages in epidural labor analgesia, and find out the optimal dose of hydromorphone.

Participants will be randomly allocated to four groups : Group 1, Group 2, Group 3 and Group 4. For those in Group 1 : they will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 2 : they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine for epidural labor analgesia.

The goal of this clinical trial is to provide a new treatment option for pregnant women in epidural labor analgesia, and to provide a basis for hydromorphone combined with ropivacaine in epidural labor analgesia.

Being tested
Hydromorphone, Sufentanil, Ropivacaine
Medical subject headings
Agnosia, Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydromorphoneDrug

    For those in Group 1 : they will be administered with 15 ug/ml hydromorphone, For those in Group 2 : they will be administered with 17.5 ug/ml hydromorphone, For those in Group 3 : they will be administered with 20 ug/ml hydromorphone

  • SufentanilDrug

    For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil

  • RopivacaineDrug

    0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms

Study groups in NCT06036797
Study groupRoleWhat they receive
Group 1ExperimentalGroup 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine
Receives: Drug: Hydromorphone; Drug: Ropivacaine
Group 2ExperimentalGroup 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine
Receives: Drug: Hydromorphone; Drug: Ropivacaine
Group 3ExperimentalGroup 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
Receives: Drug: Hydromorphone; Drug: Ropivacaine
Group 4Active comparatorGroup 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine
Receives: Drug: Sufentanil; Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale(VAS)

    VAS will be monitored and recorded at 6 time points, including the time of entering the operating room(Time 0), when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), when the first dose is given for 30 minutes(Time 3), 30 minutes after delivery (Time 4), and 60 minutes after delivery (Time 5). The VAS consists of a 10 cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).

    Measured: 30 minutes-1 hour

Secondary outcomes (7)

  1. Heart rate(HR)

    HR will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).

    Measured: 30 minutes-1.5 hours

  2. Mean arterial pressure(MAP)

    MAP will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).

    Measured: 30 minutes-1.5 hours

  3. Pulse oxygen saturation

    Pulse oxygen saturation will be monitored and recorded at 5 time points, including the time of entering the operating room(Time 0),when the first dose is given for 5 minutes(Time 1), when the first dose is given for 15 minutes(Time 2), 30 minutes after delivery (Time 3), and 60 minutes after delivery (Time 4).

    Measured: 30 minutes-1.5 hours

  4. Duration of analgesia

    Defined as the time from labor analgesia to delivery of the fetus.

    Measured: 30 minutes-1.5 hours

  5. The number of compressions

    The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.

    Measured: 30 minutes-1.5 hours

  6. Adverse reactions

    The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).

    Measured: 30 minutes-1.5 hours

  7. The Apgar scores

    The Apgar scores of 1 minute and 5 minutes after birth will be recorded.

    Measured: 1 minute and 5 minutes after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start17 Sep 2023
  3. Primary completion17 Oct 2023 (estimated)
  4. Study completion17 Oct 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036797
Sponsor's protocol ID
MCHH_003
Status last verified
Oct 2023
First submitted
7 Sep 2023
Last updated
26 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydromorphone, Sufentanil and Ropivacaine in people with Analgesia and Labor Pain, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.

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 3 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 26 Oct 2023. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Na Li, MD (+862763490107, lina@hbfy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale(VAS) (time frame: 30 minutes-1 hour). 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 NCT06036797.

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 26 Oct 2023.

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