Back to resultsEffect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
Primary Purpose
Analgesia, Labor Pain
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hydromorphone
Sufentanil
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria: no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent Exclusion Criteria: poor respiratory functions severe cardiovascular diseases
Sites / Locations
- Maternal and Child Health Hospital of Hubei Province
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
H1 group
H2 group
H3 group
SF group
Arm Description
H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine
H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine
H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Duration of analgesia
Defined as the time from labor analgesia to delivery of the fetus.
The number of compressions
The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.
Adverse reactions
The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).
The Apgar scores
The Apgar scores of 1 and 5 minutes after birth will be recorded.
Full Information
NCT ID
NCT05901441
First Posted
June 4, 2023
Last Updated
June 4, 2023
Sponsor
Maternal and Child Health Hospital of Hubei Province
1. Study Identification
Unique Protocol Identification Number
NCT05901441
Brief Title
Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
Official Title
Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternal and Child Health Hospital of Hubei Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H1 group
Arm Type
Experimental
Arm Description
H1 group will be administered with15 ug/ml hydromorphone and 0.08% ropivacaine
Arm Title
H2 group
Arm Type
Experimental
Arm Description
H2 group will be administered with17.5 ug/ml hydromorphone and 0.08% ropivacaine
Arm Title
H3 group
Arm Type
Experimental
Arm Description
H3 group will be administered with 20 ug/ml hydromorphone and 0.08% ropivacaine
Arm Title
SF group
Arm Type
Active Comparator
Arm Description
SF group will be administered with 40 ug/ml sufentanil and 0.08% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
For those in SF group: they will be administered with 40 ug/ml sufentanil
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
0.08% ropivacaine will be co-administrated for epidural labor analgesia in four arms
Primary Outcome Measure Information:
Title
Visual Analogue Scale(VAS)
Description
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).
Time Frame
30 minutes-1 hour
Secondary Outcome Measure Information:
Title
Heart rate(HR)
Description
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).
Time Frame
30 minutes-1.5 hours
Title
Mean arterial pressure(MAP)
Description
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).
Time Frame
30 minutes-1.5 hours
Title
Pulse oxygen saturation
Description
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).
Time Frame
30 minutes-1.5 hours
Title
Duration of analgesia
Description
Defined as the time from labor analgesia to delivery of the fetus.
Time Frame
30 minutes-1.5 hours
Title
The number of compressions
Description
The number of compressions by electronic analgesia pump from labor analgesia to delivery of the fetus.
Time Frame
30 minutes-1.5 hours
Title
Adverse reactions
Description
The occurrence of adverse reactions(nausea, vomiting, skin itching and other adverse reactions).
Time Frame
30 minutes-1.5 hours
Title
The Apgar scores
Description
The Apgar scores of 1 and 5 minutes after birth will be recorded.
Time Frame
30 minutes-1.5 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
no contraindication of intraspinal anesthesia the American Society of Anesthesiologists(ASA) physical status ranked Ⅰ-Ⅱ competent to provide informed consent
Exclusion Criteria:
poor respiratory functions severe cardiovascular diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Na Li, MD
Organizational Affiliation
Maternal and Child Health Hospital of Hubei Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Child Health Hospital of Hubei Province
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
12. IPD Sharing Statement
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Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
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