AnalgesiaPhase 2NCT05901441

Effect of Epidural Hydromorphone Combined With Ropivacaine in 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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: 1 Jun 2022to 30 May 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

no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent

Who cannot join

poor respiratory functions severe cardiovascular diseases

Trial locations and contacts

1 site in 1 country.

China1 site

Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000

Other trials in China

About this study

Participants will be randomly allocated to four groups: H1 group,H2 group,H3 group and SF group.For those in H1 group: they will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in H3 group: they will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine for epidural labor analgesia, For those in SF group: they will be administered with 40 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.

Conditions: Analgesia, Labor Pain
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 H1 group: they will be administered with15 ug/ml hydromorphone, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone , For those in H3 group: they will be administered with 20 ug/ml hydromorphone
SufentanilDrug
For those in SF group: they will be administered with 40 ug/ml sufentanil
RopivacaineDrug
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms

Study groups in NCT05901441
Study group	Role	What they receive
H1 group	Experimental	H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine Receives: Drug: Hydromorphone; Drug: Ropivacaine
H2 group	Experimental	H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine Receives: Drug: Hydromorphone; Drug: Ropivacaine
H3 group	Experimental	H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine Receives: Drug: Hydromorphone; Drug: Ropivacaine
SF group	Active comparator	SF group will be administered with 40 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.

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)

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
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
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
Duration of analgesia
Defined as the time from labor analgesia to delivery of the fetus.
Measured: 30 minutes-1.5 hours
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
Adverse reactions
The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).
Measured: 30 minutes-1.5 hours
The Apgar scores
The Apgar scores of 1 and 5 minutes after birth will be recorded.
Measured: 30 minutes-1.5 hours

Timeline

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

1 Jun 202230 May 2023

First posted13 Jun 2023
Study start1 Jun 2022
Primary completion30 May 2023
Study completion30 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnalgesiaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05901441
Sponsor's protocol ID: MCHH_002
Status last verified: Jun 2023
First submitted: 4 Jun 2023
Last updated: 13 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
ClinicalTrials.gov ID: NCT05901441
Acronym / sponsor ID: MCHH_002
Conditions: Analgesia, Labor Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 30 May 2023 (actual)
Study completion: 30 May 2023 (actual)
First posted: 13 Jun 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
H1 group	Experimental	Drug: Hydromorphone, Drug: RopivacaineH1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine
H2 group	Experimental	Drug: Hydromorphone, Drug: RopivacaineH2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine
H3 group	Experimental	Drug: Hydromorphone, Drug: RopivacaineH3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
SF group	Active comparator	Drug: Sufentanil, Drug: RopivacaineSF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent

Key exclusion criteria (1 listed)

poor respiratory functions severe cardiovascular diseases

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
HydromorphoneFor those in H1 group: they will be administered with15 ug/ml hydromorphone, For those in H2 group: they will be administered with17.5 ug/ml hydromorphone , For those in H3 group: they will be administered with 20 ug/ml hydromorphone	Drug	H1 group, H2 group, H3 group
SufentanilFor those in SF group: they will be administered with 40 ug/ml sufentanil	Drug	SF group
Ropivacaine0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms	Drug	H1 group, H2 group, H3 group, SF group

Primary outcome

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

7 secondary outcomes

Heart rate(HR)
Time frame: 30 minutes-1.5 hours
Mean arterial pressure(MAP)
Time frame: 30 minutes-1.5 hours
Pulse oxygen saturation
Time frame: 30 minutes-1.5 hours
Duration of analgesia
Time frame: 30 minutes-1.5 hours
The number of compressions
Time frame: 30 minutes-1.5 hours
Adverse reactions
Time frame: 30 minutes-1.5 hours
The Apgar scores
Time frame: 30 minutes-1.5 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 13 Jun 2023.

Related trials for Analgesia

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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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.

Na Li, MD principal investigator

Maternal and Child Health Hospital of Hubei Province

1 site in 1 country: see every site and its status.

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 1 inclusion and 1 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 13 Jun 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?

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?

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 NCT05901441.

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 13 Jun 2023.