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

• Sponsor: Maternal and Child Health Hospital of Hubei Province (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06036797
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 4
• Anticipated Duration (Days): 30
• Patients Per Site Per Month: 243.5

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia; Labor Pain	Drug: Hydromorphone; Drug: Sufentanil; Drug: Ropivacaine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial
• Anticipated Study Start Date: Sep 17, 2023
• Anticipated Primary Completion Date: Oct 17, 2023
• Anticipated Study Completion Date: Oct 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group 1 will be administered with 15 ug/ml hydromorphone and 0.08% ropivacaine	Drug: Hydromorphone; 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; Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Experimental: Group 2 Group 2 will be administered with 17.5 ug/ml hydromorphone and 0.08% ropivacaine	Drug: Hydromorphone; 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; Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Experimental: Group 3 Group 3 will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine	Drug: Hydromorphone; 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; Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Active Comparator: Group 4 Group 4 will be administered with 0.4 ug/ml sufentanil and 0.08% ropivacaine	Drug: Sufentanil; For those in Group 4 : they will be administered with 0.4 ug/ml sufentanil; Drug: Ropivacaine; 0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms

Outcome Measures

Primary Outcome Measures

1. Visual Analogue Scale(VAS) [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).

Secondary Outcome Measures

1. Heart rate(HR) [30 minutes-1.5 hours]

   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).

2. Mean arterial pressure(MAP) [30 minutes-1.5 hours]

   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).

3. Pulse oxygen saturation [30 minutes-1.5 hours]

   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).

4. Duration of analgesia [30 minutes-1.5 hours]

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

5. The number of compressions [30 minutes-1.5 hours]

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

6. Adverse reactions [30 minutes-1.5 hours]

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

7. The Apgar scores [1 minute and 5 minutes after birth]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status II

• a single fetus

• competent to provide informed consent

Exclusion Criteria:

• severe respiratory diseases including hypoxemia, respiratory failure and severe pneumonia

• severe circulatory diseases including acute decompensated heart failure and peripartum cardiomyopathy

• placenta previa

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei	China	430000

Sponsors and Collaborators

• Maternal and Child Health Hospital of Hubei Province

Investigators

• Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Na, Deputy Chief Physician, Maternal and Child Health Hospital of Hubei Province
• ClinicalTrials.gov Identifier: NCT06036797
• Other Study ID Numbers: MCHH_003
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Labor Pain; Sufentanil; Hydromorphone; Ropivacaine

Study Results

No Results Posted as of Sep 14, 2023