Post Operative PainNCT05474014
Superior Trunk Block Applied for Upper Arm Surgery
A study testing superior trunk block in people with Post Operative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. Providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- superior trunk block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2022to 1 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent upper arm surgery
Who cannot join
- Previous local anesthetic allergy,
- Having a bleeding diathesis disorder,
- Mental disorder,
- Allergic to the drugs used,
- Patients who did not consent to participate in the study,
- Presence of infection in the block area,
- Patients with a body mass index above 30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Investigation of the Effectiveness of Superior Trunk Block Applied for Upper Arm Surgery Operation Analgesia
Nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. Providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery.
In this study aimed to investigate the effect of superior trunk block application on postoperative analgesic and motor functions.
- Conditions
- Post Operative Pain
- Being tested
- superior trunk block, intravenous patient-controlled analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior trunk blockProcedure or surgery
Local anesthetic injection will be applied to the superior trunk of the brachial plexus accompanied by ultrasonography.
intravenous patient-controlled analgesiaDrug
Analgesics will be given using a patient-controlled analgesia device.
| Study group | Role | What they receive |
|---|---|---|
| superior trunk block | Active comparator | Ultrasound guided superior trunk block with 10 ml % 0.25 bupivacaine
+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. Receives: Procedure: superior trunk block; Drug: intravenous patient-controlled analgesia |
| tramadol | Active comparator | 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. Receives: Drug: intravenous patient-controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
Measured: Postoperative 24 hours
Secondary outcomes (4)
tramadol consumption amount
tramadol consumption amount with patient-controlled analgesia device
Measured: Postoperative 24 hours
additional analgesic use amount
The amount of paracetamol (intravenous, 1 g) or non-steroidal anti-inflammatory drug to be administered to patients with a Visuel analog scale above 5 after the operation.
Measured: Postoperative 24 hours
postoperative complications
shortness of breath, hiccups, hoarseness
Measured: Postoperative 24 hours
Horner syndrome
Horner syndrome is a rare condition classically presenting with partial ptosis (drooping or falling of upper eyelid), miosis (constricted pupil), and facial anhidrosis (loss of sweating) due to a disruption in the sympathetic nerve supply
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start20 Jul 2022
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Assoc. PhD., Principal investigator, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474014
- Sponsor's protocol ID
- 2022/06-12
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Superior Trunk Block Applied for Upper Arm Surgery Operation Analgesia
- ClinicalTrials.gov ID
- NCT05474014
- Acronym / sponsor ID
- 2022/06-12
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 26 Jul 2022 (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.
Nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. Providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery.
In this study aimed to investigate the effect of superior trunk block application on postoperative analgesic and motor functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| superior trunk block | Active comparator | Procedure: superior trunk block, Drug: intravenous patient-controlled analgesiaUltrasound guided superior trunk block with 10 ml % 0.25 bupivacaine + 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. |
| tramadol | Active comparator | Drug: intravenous patient-controlled analgesia400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA (patient-controlled analgesia): 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class
- Underwent upper arm surgery
Key exclusion criteria (7 listed)
- Previous local anesthetic allergy,
- Having a bleeding diathesis disorder,
- Mental disorder,
- Allergic to the drugs used,
- Patients who did not consent to participate in the study,
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 |
|---|---|---|
| superior trunk blockLocal anesthetic injection will be applied to the superior trunk of the brachial plexus accompanied by ultrasonography. | Procedure or surgery | superior trunk block |
| intravenous patient-controlled analgesiaAnalgesics will be given using a patient-controlled analgesia device. | Drug | superior trunk block, tramadol |
Primary outcome
Visual Analog Scale
Time frame: Postoperative 24 hours
Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain)
4 secondary outcomes
tramadol consumption amount
Time frame: Postoperative 24 hours
additional analgesic use amount
Time frame: Postoperative 24 hours
postoperative complications
Time frame: Postoperative 24 hours
Horner syndrome
Time frame: Postoperative 24 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 25 Jan 2024.
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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.
Korgün Ökmen, Assoc. PhD. principal investigator
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superior trunk block in people with Post Operative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 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 25 Jan 2024. 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 Turkey (Türkiye). 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. 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?
Visual Analog Scale (time frame: Postoperative 24 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 25 Jan 2024.