Butorphanol in Pain Following Ablation for Hepatic Tumor
Primary Purpose
Visceral Pain, Microwave Ablation, Hepatic Tumor
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Butorphanol
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Visceral Pain
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.
Sites / Locations
- Jinling Hosipiatl
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Butorphanol
normal saline
Arm Description
Outcomes
Primary Outcome Measures
Visceral Pain
VAS score of visceral pain
Secondary Outcome Measures
Visceral Pain
VAS score of visceral pain
Full Information
NCT ID
NCT06031129
First Posted
August 29, 2023
Last Updated
September 2, 2023
Sponsor
Bibo Wang
Collaborators
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06031129
Brief Title
Butorphanol in Pain Following Ablation for Hepatic Tumor
Official Title
Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bibo Wang
Collaborators
Eastern Hepatobiliary Surgery Hospital
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Pain, Microwave Ablation, Hepatic Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Butorphanol
Arm Type
Experimental
Arm Title
normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Butorphanol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline contain 0.9% NaCl sodium.
Primary Outcome Measure Information:
Title
Visceral Pain
Description
VAS score of visceral pain
Time Frame
during the surgery
Secondary Outcome Measure Information:
Title
Visceral Pain
Description
VAS score of visceral pain
Time Frame
6-hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Jinling Hosipiatl
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
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Butorphanol in Pain Following Ablation for Hepatic Tumor
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