Butorphanol in Pain Following Ablation for Hepatic Tumor

• Sponsor: Bibo Wang (Other)
• Overall Status: Completed
• CT.gov ID: NCT06031129
• Collaborator: Eastern Hepatobiliary Surgery Hospital (Other)
• Enrollment: 300
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 56.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Visceral Pain; Microwave Ablation; Hepatic Tumor	Drug: Butorphanol; Drug: normal saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial
• Actual Study Start Date: Mar 1, 2023
• Actual Primary Completion Date: Jul 30, 2023
• Actual Study Completion Date: Aug 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Butorphanol	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
Placebo Comparator: normal saline	Drug: normal saline; normal saline contain 0.9% NaCl sodium.

Outcome Measures

Primary Outcome Measures

1. Visceral Pain [during the surgery]

   VAS score of visceral pain

Secondary Outcome Measures

1. Visceral Pain [6-hour after surgery]

   VAS score of visceral pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinling Hosipiatl	Nanjing	Jiangsu	China	200000

Sponsors and Collaborators

• Bibo Wang
• Eastern Hepatobiliary Surgery Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bibo Wang, Principal Investigator of Oncology Department, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT06031129
• Other Study ID Numbers: Jinling WBB
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Liver Neoplasms; Visceral Pain; Butorphanol

Study Results

No Results Posted as of Sep 11, 2023