Butorphanol in Pain Following Ablation for Hepatic Tumor

Visceral Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06031129
• Other study ID #: Jinling WBB
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 9, 2023

Study information

• Verified date: September 2023
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 9, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Tumor
• Liver Neoplasms
• Microwave Ablation
• Visceral Pain

Intervention

Drug:
• 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
• normal saline
normal saline contain 0.9% NaCl sodium.

Locations

Country	Name	City	State
China	Jinling Hosipiatl	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Bibo Wang	Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral Pain	VAS score of visceral pain	during the surgery
Secondary	Visceral Pain	VAS score of visceral pain	6-hour after surgery