Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section

Phase 4

Not yet recruiting

• Conditions: Post-surgical Pain
• Interventions: Drug: Hydromorphone hydrochloride low dose; Drug: Hydromorphone hydrochloride high dose; Drug: 0.9% sodium chloride

• Registration Number: NCT06823180
• Lead Sponsor: Liquan Liang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-03-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose of hydromorphone hydrochloride was given to the drug group	Hydromorphone hydrochloride low dose	15min before the end of the operation, 0.1mg hydromorphone hydrochloride was injected epidural into the low-dose group for preemptive analgesia.
High dose of hydromorphone hydrochloride was given to the drug group	Hydromorphone hydrochloride high dose	15min before the end of the operation, 0.3mg hydromorphone hydrochloride was injected epidural into the high dose group for preemptive analgesia.
control group	0.9% sodium chloride	15min before the end of the operation, the control group was simply given equal dose 0.9% sodium chloride injection.

Primary Outcome Measures

Name	Time	Method
VAS score	24 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
The number of PCA compressions after surgery	48 hours after surgery
Satisfaction evaluation	Before discharge	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.
Gastrointestinal peristalsis recovery time	72 hours after surgery	The recovery time of bowel sound, anal exhaust and defecation were recorded.
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）	72 hours after surgery	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.
pruritus	72 hours after surgery	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.
Quality of life assessment	7 days after discharge	The EQ-5D-5L™ tool is used to measure patients' quality of life in five areas, including mobility, self-care, daily activities, pain and discomfort, and anxiety/depression.