Butorphanol in Pain Following Ablation for Hepatic Tumor

NCT06031129 | Completed

• 1 other identifier: Jinling WBB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Pain; Microwave Ablation; Hepatic Tumor

Outcome Measures

Primary Outcomes (1)

• Visceral Pain

  VAS score of visceral pain

  during the surgery

Secondary Outcomes (1)

• Visceral Pain

  6-hour after surgery

Study Arms (2)

Butorphanol

EXPERIMENTAL

Drug: Butorphanol

normal saline

PLACEBO COMPARATOR

Drug: normal saline

Interventions

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

Butorphanol

normal saline DRUG

normal saline contain 0.9% NaCl sodium.

normal saline

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients performing Microwave Ablation sign the informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bibo Wang: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (1)

Jinling Hosipiatl

Nanjing, Jiangsu, 200000, China

Location

MeSH Terms

Conditions

Visceral Pain; Carcinoma, Hepatocellular

Interventions

Butorphanol; Saline Solution

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator of Oncology Department

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 11, 2023
• Study Start: March 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 9, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

CN (1)