Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section

NCT06823180 | Completed Phase 4 DMC

• 1 other identifier: 2024-128IITFS
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• VAS score

  VAS score was used to evaluate the pain in each period after obstetric surgery. A strip marked with a scale of 0-10 was taken, where 0 indicated no pain, the pain degree increased with the increase of the score, and 10 indicated the most pain. The mothers chose the score matching their own pain degree. Mild pain: 0\<VAS\<4 ; Moderate pain :4 ≤VAS\< 7; Severe pain :7 ≤VAS\<9; Extreme pain: VAS≥9.

  24 hours after surgery

Secondary Outcomes (7)

• The number of PCA compressions after surgery

  48 hours after surgery

• Satisfaction evaluation

  Before discharge

• Gastrointestinal peristalsis recovery time

  72 hours after surgery

• The time it takes to get out of bed for the first time after surgery

  96 hours after surgery

• The time between the end of surgery and lactation

  72 hours after surgery

Study Arms (3)

Low dose of hydromorphone hydrochloride was given to the drug group

EXPERIMENTAL

15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected epidural into the low-dose group for preemptive analgesia.

Drug: Hydromorphone hydrochloride low dose

High dose of hydromorphone hydrochloride was given to the drug group

EXPERIMENTAL

15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected epidural into the high dose group for preemptive analgesia.

Drug: Hydromorphone hydrochloride high dose

control group

PLACEBO COMPARATOR

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

Drug: 0.9% sodium chloride

Interventions

Hydromorphone hydrochloride low dose 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.

Low dose of hydromorphone hydrochloride was given to the drug group

Hydromorphone hydrochloride high dose 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.

High dose of hydromorphone hydrochloride was given to the drug group

0.9% sodium chloride DRUG

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

control group

Eligibility Criteria

• Age: 22 Years - 45 Years
• Gender Eligibility Details: Our study focused on women who were expecting to give birth, so we included only women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Liquan Liang: lead

Study Sites (1)

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330038, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 12, 2025
• Study Start: March 3, 2025
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)