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Completed

NCT Number: NCT06031129

Butorphanol in Pain Following Ablation for Hepatic Tumor

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.

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Key information

Conditions

Visceral Pain Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatic Tumor Liver Diseases Liver Neoplasms Microwave Ablation Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinling Hosipiatl

Nanjing, Jiangsu, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Butorphanol

Drug

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

normal saline

Drug

normal saline contain 0.9% NaCl sodium.

Primary outcomes

  1. Visceral Pain

    Time frame: during the surgery

    VAS score of visceral pain

Secondary outcomes

  1. Visceral Pain

    Time frame: 6-hour after surgery

    VAS score of visceral pain

Sponsors and collaborators

Lead sponsor

Bibo Wang

Other

Collaborators

  • Eastern Hepatobiliary Surgery Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 11, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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