Visceral PainNCT06031129
Butorphanol in Pain Following Ablation for Hepatic Tumor
A study testing Butorphanol and normal saline in people with Visceral Pain and Microwave Ablation, run by Bibo Wang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Visceral Pain, Microwave Ablation, Hepatic Tumor
- What is being tested?
- Butorphanol and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 9 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients performing Microwave Ablation sign the informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial
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
- Being tested
- Butorphanol, normal saline
- Medical subject headings
- Visceral Pain, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButorphanolDrug
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 salineDrug
normal saline contain 0.9% NaCl sodium.
| Study group | Role | What they receive |
|---|---|---|
| Butorphanol | Experimental | Not described Receives: Drug: Butorphanol |
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral Pain
VAS score of visceral pain
Measured: during the surgery
Secondary outcomes (1)
Visceral Pain
VAS score of visceral pain
Measured: 6-hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Mar 2023
- Primary completion30 Jul 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bibo Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Sponsor-investigator, Bibo Wang, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031129
- Sponsor's protocol ID
- Jinling WBB
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06031129
- Acronym / sponsor ID
- Jinling WBB
- Conditions
- Visceral Pain, Microwave Ablation, Hepatic Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bibo WangUniversity, hospital or other
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butorphanol | Experimental | Drug: Butorphanol |
| normal saline | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients performing Microwave Ablation sign the informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ButorphanolThe 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 | Drug | Butorphanol |
| normal salinenormal saline contain 0.9% NaCl sodium. | Drug | normal saline |
Primary outcome
Visceral Pain
Time frame: during the surgery
VAS score of visceral pain
1 secondary outcome
Visceral Pain
Time frame: 6-hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butorphanol and normal saline in people with Visceral Pain and Microwave Ablation, run by Bibo Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral Pain (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.