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CompletedNCT06031129Updated Sep 11, 2023

Butorphanol in Pain Following Ablation for Hepatic Tumor

An interventional study of Butorphanol and normal saline in Visceral Pain, Microwave Ablation and Hepatic Tumor, sponsored by Bibo Wang. Completed at 1 site in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-11.

Sponsored by Bibo Wang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Visceral Pain
  • Microwave Ablation
  • Hepatic Tumor
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 300 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

This is the only study on the registry with Bibo Wang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

patients performing Microwave Ablation sign the informed consent

Exclusion criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Butorphanol

    Drug: Butorphanol

  • Placebo comparator
    normal saline

    Drug: normal saline

Interventions

  • DrugButorphanol

    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

  • Drugnormal saline

    normal saline contain 0.9% NaCl sodium.

06

What researchers measure

Primary outcomes

  1. Visceral Pain

    VAS score of visceral pain

    Time frame: during the surgery

Secondary outcomes

  1. Visceral Pain

    VAS score of visceral pain

    Time frame: 6-hour after surgery

07

Study locations

1 site
  • Jinling Hosipiatl
    Nanjing, Jiangsu 200000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06031129
Lead sponsor
Bibo Wang
Collaborators
Eastern Hepatobiliary Surgery Hospital
Responsible party
Bibo Wang (Principal Investigator of Oncology Department, Jinling Hospital, China) — Sponsor-investigator
First posted
Sep 11, 2023
Start date
Mar 1, 2023
Primary completion
Jul 30, 2023
Completion
Aug 9, 2023
Last update
Sep 11, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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