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Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section

NCT06823180 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Post-surgical Pain

Interventions

DRUG

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.

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.

DRUG

0.9% sodium chloride

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

Sponsors & Collaborators

  • Liquan Liang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2025-08-28
Completion
2025-08-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823180 on ClinicalTrials.gov