Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section

NCT ID: NCT06823180

Last Updated: 2025-09-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2025-08-28

Brief Summary

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Acute pain often occurs after cesarean section, which can lead to stress and inflammatory response in the body, which will not only affect the postpartum recovery speed of the puerpera, but also inhibit the secretion of prolactin to a certain extent and reduce the secretion of milk. Epidural anesthesia is a common anesthesia method for cesarean section, which has the advantages of easy operation and little influence on the fetus. Preemptive analgesia can effectively block the transmission of harmful stimuli and reduce the degree of pain after cesarean section. Hydromorphone hydrochloride is a derivative of morphine, which has the advantages of rapid onset and good analgesic effect, and has been widely used in clinic. However, it is not clear whether epidural injection of hydromorphone hydrochloride for preanalgesia can bring clinical benefits to puerpera, and the optimal dose of hydromorphone hydrochloride for cesarean section is also unclear.

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.

Detailed Description

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Conditions

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Post-surgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Group Type EXPERIMENTAL

Hydromorphone hydrochloride low dose

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Hydromorphone hydrochloride high dose

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

0.9% sodium chloride

15min before the end of the operation, 0.9% sodium chloride injection was given in the control group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parturients with indications for cesarean section;
* American Association of Anesthesiologists (ASA) Grade I - II;
* No history of sedative drugs or opioid abuse;
* Volunteer to join the study

Exclusion Criteria

* People with coagulation disorders;
* preoperative use of analgesia, non-steroidal drugs;
* Abnormal liver and kidney function;
* Postoperative drainage is urgently needed.
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Liquan Liang

OTHER

Sponsor Role lead

Responsible Party

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Liquan Liang

Doctor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Site Status

Countries

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China

Other Identifiers

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2024-128IITFS

Identifier Type: -

Identifier Source: org_study_id

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