Butorphanol in Pain Following Ablation for Hepatic Tumor

NCT06031129 — Not applicable, Completed, 300 participants, Bibo Wang

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06031129
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: double, treatment
Enrollment	300 (Actual)
Sponsor	Bibo Wang (Other); collaborators: Eastern Hepatobiliary Surgery Hospital
Conditions	Visceral Pain, Microwave Ablation, Hepatic Tumor
Interventions	Butorphanol, normal saline (Drug)
Dates	start 2023-03-01, primary completion 2023-07-30, completion 2023-08-09, first posted 2023-09-11, last updated 2023-09-11
Locations	1 site in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Butorphanol	Experimental	Drug: Butorphanol
normal saline	Placebo comparator	Drug: normal saline

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.

+Outcome measures

Primary outcomes

Visceral Pain [during the surgery]: VAS score of visceral pain

Secondary outcomes

Visceral Pain [6-hour after surgery]: VAS score of visceral pain

+Eligibility

Sex: All, ages: 20 Years to 75 Years

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.

+Locations (1)

Facility	City	Country	Status
Jinling Hosipiatl	Nanjing, Jiangsu	China