Pain, PostoperativeNCT03913650
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
A study testing 0.25% bupivacaine in people with Pain, Postoperative and Change; Circulatory, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
Trial summary
To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pain, Postoperative, Change; Circulatory, Surgical Injury
- What is being tested?
- 0.25% bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 May 2017to 31 Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of limb fracture
- must receiving orthopedic surgery
Who cannot join
- With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
I-Cheng Lu
Kaohsiung City, 807
Kaohsiung Municipal Siaogang Hospital
Kaohsiung City, 812
About this study
Official title: Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery
To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain
Read the detailed description
In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours
- Conditions
- Pain, Postoperative, Change; Circulatory, Surgical Injury
- Being tested
- 0.25% bupivacaine
- Keywords
- peripheral nerve block, IL-6, post-operative pain, limb surgery
- Medical subject headings
- Pain, Postoperative, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% bupivacaineProcedure or surgery
Also called nerve block with 0.25% bupivacaine
nerve block procedure will be decided by patients' will for post-op pain
| Study group | Role | What they receive |
|---|---|---|
| Nerve block(+) | Active comparator | patient accept nerve block for post-op pain control Receives: Procedure: 0.25% bupivacaine |
| Morphine | Sham comparator | patient received morphine for post-op pain control Receives: Procedure: 0.25% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak pain intensity in the postoperative care unit
pain score evaluated by pain score
Measured: 2 hours
Secondary outcomes (1)
change of perioperative IL-6 level
blood samples assessed by ELISA
Measured: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start15 May 2017
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Municipal Hsiaokang Hospital
- Responsible party
- Principal investigator, I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- I-Cheng Lu, MD, PHD, Study chair, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913650
- Sponsor's protocol ID
- KMUH-IRB-F(I)-20170007
- Status last verified
- Feb 2020
- First submitted
- 17 Sep 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03913650
- Acronym / sponsor ID
- KMUH-IRB-F(I)-20170007
- Conditions
- Pain, Postoperative, Change; Circulatory, Surgical Injury
- Keywords
- peripheral nerve block, IL-6, post-operative pain, limb surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Municipal Hsiaokang Hospital
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Apr 2019 (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.
To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain
Detailed description
In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block(+) | Active comparator | Procedure: 0.25% bupivacainepatient accept nerve block for post-op pain control |
| Morphine | Sham comparator | Procedure: 0.25% bupivacainepatient received morphine for post-op pain control |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of limb fracture
- must receiving orthopedic surgery
Key exclusion criteria (1 listed)
- With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine
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 |
|---|---|---|
| 0.25% bupivacaineAlso: nerve block with 0.25% bupivacainenerve block procedure will be decided by patients' will for post-op pain | Procedure or surgery | Morphine, Nerve block(+) |
Primary outcome
peak pain intensity in the postoperative care unit
Time frame: 2 hours
pain score evaluated by pain score
1 secondary outcome
change of perioperative IL-6 level
Time frame: up to 6 hours
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 18 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
I-Cheng Lu, MD, PHD study chair
Kaohsiung Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.25% bupivacaine in people with Pain, Postoperative and Change; Circulatory, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
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 2 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
peak pain intensity in the postoperative care unit (time frame: 2 hours). 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 18 Feb 2020.