Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section (HHEPA)

Clinical Effect of Hydromorphone Hydrochloride Epidural Preemptive Analgesia on Postoperative Pain After Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Post-surgical Pain
• Intervention / Treatment: Drug: Hydromorphone hydrochloride low dose; Drug: Hydromorphone hydrochloride high dose; Drug: 0.9% sodium chloride

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Jiangxi Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Placebo Comparator: control group; 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; 15min before the end of the operation, 0.9% sodium chloride injection was given in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of PCA compressions after surgery		48 hours after surgery
Satisfaction evaluation	Patients' satisfaction was assessed by HCAHPS survey. The survey was designed to assess patient inpatient experience, including nurse care, physician communication, hospital environment, hospital experience, discharge information provision, and overall hospital evaluation.	Before discharge
Gastrointestinal peristalsis recovery time	The recovery time of bowel sound, anal exhaust and defecation were recorded.	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
Postoperative nausea and vomiting（PONV）	PONV rating standards of WHO are adopted. Specifically: Grade I is no nausea, vomiting; Grade II was mild nausea, abdominal discomfort, but no vomiting; Grade III is nausea and vomiting, but there is no content spit out; Grade IV is severe vomiting, with vomiting of stomach contents and requiring medical control.	72 hours after surgery
pruritus	The numeric rating scale (NRS) was used to evaluate the degree of postoperative pruritus. Itching is numerically graded on the NRS scale, with 0 indicating no itching and 10 indicating the most severe itching. The degree of itching increased with the increase of the score. Mild pruritus :0<NRS<4 ; Moderate pruritus :4 ≤NRS< 7; Severe pruritus :7 ≤NRS<9; Extreme pruritus :NRS≥9.	72 hours after surgery

Collaborators and Investigators

• Sponsor: Liquan Liang

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Actual): August 28, 2025
• Study Completion (Actual): August 28, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Hydromorphone; Saline Solution
• Other Study ID Numbers: 2024-128IITFS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No