Clinical trial NCT06823180: Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section
Official title: Clinical Effect of Hydromorphone Hydrochloride Epidural Preemptive Analgesia on Postoperative Pain After Cesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Post-surgical Pain
Lead sponsor: Jiangxi Provincial People's Hopital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 105
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: VAS score
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: The number of PCA compressions after surgery
timeFrame: 48 hours after surgery
measure: Satisfaction evaluation
timeFrame: Before discharge
measure: Gastrointestinal peristalsis recovery time
timeFrame: 72 hours after surgery
measure: The time it takes to get out of bed for the first time after surgery
timeFrame: 96 hours after surgery
measure: The time between the end of surgery and lactation
timeFrame: 72 hours after surgery
measure: Postoperative nausea and vomiting（PONV）
timeFrame: 72 hours after surgery
measure: pruritus
timeFrame: 72 hours after surgery
measure: Quality of life assessment
timeFrame: 7 days after discharge
Other outcomes:
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