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

Liquan Liang

Status and phase: Completed; Phase 4

Conditions: Post-surgical Pain

Treatments: Drug: Hydromorphone hydrochloride low dose; Drug: 0.9% sodium chloride; Drug: Hydromorphone hydrochloride high dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06823180

2024-128IITFS

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: Female

Ages: 22 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

Low dose of hydromorphone hydrochloride was given to the drug group

Experimental group

Description:

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

Treatment:

Drug: Hydromorphone hydrochloride low dose

High dose of hydromorphone hydrochloride was given to the drug group

Experimental group

Description:

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

Treatment:

Drug: Hydromorphone hydrochloride high dose

control group

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% sodium chloride