Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section
NCT ID: NCT06823180
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2025-03-03
2025-08-28
Brief Summary
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The parturient women who met the inclusion criteria were randomly divided into 3 groups: control group, hydromorphone hydrochloride low-dose administration group and hydromorphone hydrochloride high-dose administration group. All women received epidural combined subarachnoid anesthesia. 15min before the end of the operation, the low-dose hydromorphone hydrochloride group was injected with 0.1mg hydromorphone hydrochloride in the epidural space, the high-dose hydromorphone hydrochloride group was injected with 0.3mg hydromorphone hydrochloride in the epidural space, and the control group was injected with 0.9% sodium chloride injection. Post-obstetric visual analogue scale (VAS) was followed up to record PCA compression times, gastrointestinal peristalsis recovery time, getting out of bed time, lactation time, and related adverse reactions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low dose of hydromorphone hydrochloride was given to the drug group
15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected epidural into the low-dose group for preemptive analgesia.
Hydromorphone hydrochloride low dose
15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected into the epidural space in the low-dose group for preemptive analgesia.
High dose of hydromorphone hydrochloride was given to the drug group
15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected epidural into the high dose group for preemptive analgesia.
Hydromorphone hydrochloride high dose
15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected into the epidural space in the high-dose group for preemptive analgesia.
control group
15min before the end of the operation, the control group was simply given equal dose 0.9% sodium chloride injection.
0.9% sodium chloride
15min before the end of the operation, 0.9% sodium chloride injection was given in the control group.
Interventions
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Hydromorphone hydrochloride low dose
15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected into the epidural space in the low-dose group for preemptive analgesia.
Hydromorphone hydrochloride high dose
15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected into the epidural space in the high-dose group for preemptive analgesia.
0.9% sodium chloride
15min before the end of the operation, 0.9% sodium chloride injection was given in the control group.
Eligibility Criteria
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Inclusion Criteria
* American Association of Anesthesiologists (ASA) Grade I - II;
* No history of sedative drugs or opioid abuse;
* Volunteer to join the study
Exclusion Criteria
* preoperative use of analgesia, non-steroidal drugs;
* Abnormal liver and kidney function;
* Postoperative drainage is urgently needed.
22 Years
45 Years
FEMALE
No
Sponsors
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Liquan Liang
OTHER
Responsible Party
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Liquan Liang
Doctor of Medicine
Locations
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Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Countries
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Other Identifiers
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2024-128IITFS
Identifier Type: -
Identifier Source: org_study_id
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