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Early analgesia after pelvic surgery by intrathecal injection of hydromorphone under accelerated rehabilitation surgery mode

Early analgesia after pelvic surgery by intrathecal injection of hydromorphone under accelerated rehabilitation surgery mode

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093466
Enrollment
Unknown
Registered
2024-12-05
Start date
2024-12-06
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological diseases

Interventions

Hydromorphone mixed with isobaric bupivacaine group (HB group):Introduce 25 G puncture needle into the subarachnoid space between L2-3 and L3-4 in a standard aseptic way, and confirm whether the punct
Simple Isobaric Bupivacaine Group (Group B):Introduce 25 G puncture needle into the subarachnoid space between L2-3 and L3-4 in a standard aseptic way, and confirm whether the puncture is in place by

Sponsors

Xing'an League People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The age is over 18 and under 65. American Society of Anesthesiologists (ASA) grades I ~ II; The results of B-ultrasound examination on admission are in line with the clinical diagnostic criteria of pelvic tumor in Obstetrics and Gynecology. Patients have indications for open surgery; No contraindication of spinal anesthesia; Patients and their families know and sign the informed consent form of this study.

Exclusion criteria

Exclusion criteria: Coagulation dysfunction; Past allergic history of hydromorphone, bupivacaine and NSAIDs; Communication barriers such as mental illness and different languages; Not cooperating to complete the puncture in spinal canal; History of paresthesia of lower limbs or peripheral nerve diseases; Those who had opioid addiction, allergy and contraindications in the past;

Design outcomes

Primary

MeasureTime frame
Visual analogue scale (VAS) scores were obtained at 6 h, 12 h, 24 h and 48 h after operation.;The number of self-controlled analgesic compressions and the cumulative amount of opioids used 48 hours after operation;Postoperative adverse reactions were recorded, including nausea, vomiting, dizziness, delirium or disorientation.;

Secondary

MeasureTime frame
Incidence rate of vascular complications in operation center (incidence rate of arrhythmia, application rate of antihypertensive drugs, application rate of antihypertensive drugs);Basic information during operation (blood pressure, heart rate, body temperature);Dosage of vasoactive drugs during operation (ephedrine, norepinephrine, atropine, urapidil, esmolol, etc.);Intraoperative infusion volume, bleeding volume and urine volume;Intraoperative complications (arrhythmia, myocardial infarction, cardiac arrest, hypoxemia, allergy, etc.);The dosage of opioids 48 hours after operation;Incidence rate of postoperative cardiovascular complications;Postoperative hospitalization days;

Countries

China

Contacts

Public ContactMa Yuhua

Xing'an League People's Hospital

3221410993@qq.com+86 138 4793 0665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026