Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy

Zhejiang University

Status and phase: Completed; Phase 4

Conditions: Thoracic Surgery, Video-Assisted; Pain, Postoperative

Treatments: Drug: Hydromorphone; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03648008

2018-014

Details and patient eligibility

About

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).

Enrollment: 171 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 70≥ Age ≥18
• Selective operation lung section with video-assisted thoracic surgery (VATS)
• III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
• Patients informed and agreed to join the study

Exclusion criteria

• Abnormal function of liver and kidney
• Allergic- dependence history of alcohol, opioids and Local anesthetics
• No noncompliance
• Mental disease history，language communication disorder，cicatricial diathesis
• Underweight or overweight（BMI<18 or >30)
• Patients not suitable for clinical subjects for other reasons
• Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.
• History of previous abnormal anaesthesia
• Women during pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups

Group M

Active Comparator group

Description:

Drug: Morphine Background: No Bolus infusion: 0.015 mg\*kg-1

Treatment:

Drug: Morphine

Group NBH

Experimental group

Description:

Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg\*kg-1

Treatment:

Drug: Hydromorphone

Group BH

Experimental group

Description:

Drug: Hydromorphone Background: 0.002 mg\*kg-1\*h-1 Bolus infusion: 0.002 mg\*kg-1

Treatment:

Drug: Hydromorphone