Clinical trial

Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial

Name

Jinling WBB

Description

The objective of this investigation was to evaluate the influence of Butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. Employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either Butorphanol (experimental group) or normal saline (control group). Primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the 6-hour mark (VAS) and comprehensive pain assessment outcomes.

Trial arms

Trial start

2023-03-01

Estimated PCD

2023-07-30

Trial end

2023-08-09

Status

Completed

Treatment

Butorphanol

The pharmacological attributes of Butorphanol, characterized by its mild impact on cardiopulmonary dynamics and demonstrated efficacy in attenuating mechanical traction-induced discomfort, culminate in an ameliorative effect on postoperative nausea and vomiting rates. Importantly, it substantively attenuates visceral postoperative pain. However, sedation can also cause dizziness, drowsiness, and other adverse reactions during recovery

Arms:

Butorphanol

normal saline

normal saline contain 0.9% NaCl sodium.

Arms:

normal saline

Size

300

Primary endpoint

Visceral Pain

during the surgery

Eligibility criteria

Inclusion Criteria: patients performing Microwave Ablation sign the informed consent Exclusion Criteria: Patients with a body mass index \> 30 kg/m2 a history of depression opioid dependence poorly controlled hypertension (systolic blood pressure \> 180 mmHg) myocardial infarction severe liver disease significant abdominal pain before surgery patients with sensory system or language dysfunctions who could not cooperate to complete the scale pregnant women.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}

Updated at

2023-09-11

1 organization

2 products

3 indications

Organization

Product

Indication

Indication

Indication

Product