Postoperative PainNCT04397549
Cervical Erector Spinae Block for Shoulder Surgery
A study testing Cervical erector spinae plane block in people with Postoperative Pain and Shoulder Surgery, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
Arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life. In addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Shoulder Surgery
- What is being tested?
- Cervical erector spinae plane block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 15 Oct 2020
- 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
- 18 -65 years of agge
- ASA I-II
- Undergoing elective shoulder surgery
Who cannot join
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs
- obesity (body mass index >35 kg/m2)
Trial locations and contacts
1 site in 1 country.
Ilker Ince contact
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya
alper kılıcaslan, prof, 905053780376, dralperkilicaslan@gmail.com
ilker ince, prof
About this study
Official title: Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
Arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life.
In addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are associated with the use of opioids to manage postoperative pain. Erector spinae plane block (ESPB) has been used in many different indications for acute pain treatment at different thoracic and lumbar levels. Recently, staining the roots of the brachial plexus has been reported in a cadaveric study of the cervical ESPB (1).
Read more
However, there are only few case reports related to efficiency and safety of this newly defined cervical ESPB technique (2) .
The primary objective of this randomized controlled is investigate the post-operative analgesic effectiveness of ultrasound guided single-shot cervical ESPB for patients undergoing arthroscopic shoulder surgery in comparison to those receiving conventional parentheral opioid analgesia alone.
Secondary objective is testing the safety of this newly defined block in terms of incidence of complications.
Read the detailed description
60 patients will be enrolled to in this study between June 2020 - October 2020. All patient will be randomly selected who will be operated for shoulder surgery. Age, weight, ASA score, body mass index, additional dissease status will be recorded. The patients will be divided in two groups. One group will have cervical ESPB before the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia.
Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period, the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 3/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be applied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.
- Conditions
- Postoperative Pain, Shoulder Surgery
- Being tested
- Cervical erector spinae plane block, Intravenous morphine patient controlled analgesia device
- Keywords
- cervical erector spinae plane block, postoperative pain, Shoulder Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical erector spinae plane blockOther
Cervical erector spinae plane block will be administered before the surgery
Intravenous morphine patient controlled analgesia deviceDevice
24 hour morphine consumption will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | Cervical Erector Spinae Plane Block administered group Receives: Other: Cervical erector spinae plane block; Device: Intravenous morphine patient controlled analgesia device |
| Control group | Sham comparator | Control group Receives: Device: Intravenous morphine patient controlled analgesia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
Measured: 24 hour postoperatively
Secondary outcomes (2)
Numering Rating Scale scores for pain
Numeric Rating Scale (NRS) for pain will be used. The Numeric Rating Scale (NRS-11) is an 11- point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 means no pain and 10 means most imaginable pain
Measured: 24 hour
Postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting will be recorded
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start15 Jun 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will randomized into two groups cervical ESP and control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Alper Kilicaslan, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Alper Kilicaslan, MD, Assoc.Prof, Principal investigator, Necmettin Erbakan University Meram Medical Facultyİlker İnce, MD, Assoc.Prof, Principal investigator, Ataturk University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397549
- Sponsor's protocol ID
- ATA-173
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
PubMed 31161549Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
PubMed 32321860
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04397549
- Acronym / sponsor ID
- ATA-173
- Conditions
- Postoperative Pain, Shoulder Surgery
- Keywords
- cervical erector spinae plane block, postoperative pain, Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 21 May 2020 (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.
Arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life.
In addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are associated with the use of opioids to manage postoperative pain. Erector spinae plane block (ESPB) has been used in many different indications for acute pain treatment at different thoracic and lumbar levels. Recently, staining the roots of the brachial plexus has been reported in a cadaveric study of the cervical ESPB (1).
However, there are only few case reports related to efficiency and safety of this newly defined cervical ESPB technique (2) .
The primary objective of this randomized controlled is investigate the post-operative analgesic effectiveness of ultrasound guided single-shot cervical ESPB for patients undergoing arthroscopic shoulder surgery in comparison to those receiving conventional parentheral opioid analgesia alone.
Secondary objective is testing the safety of this newly defined block in terms of incidence of complications.
Detailed description
60 patients will be enrolled to in this study between June 2020 - October 2020. All patient will be randomly selected who will be operated for shoulder surgery. Age, weight, ASA score, body mass index, additional dissease status will be recorded. The patients will be divided in two groups. One group will have cervical ESPB before the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia.
Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period, the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 3/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be applied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will randomized into two groups cervical ESP and control.
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Other: Cervical erector spinae plane block, Device: Intravenous morphine patient controlled analgesia deviceCervical Erector Spinae Plane Block administered group |
| Control group | Sham comparator | Device: Intravenous morphine patient controlled analgesia deviceControl group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 -65 years of agge
- ASA I-II
- Undergoing elective shoulder surgery
Key exclusion criteria (5 listed)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs
- obesity (body mass index >35 kg/m2)
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 |
|---|---|---|
| Cervical erector spinae plane blockCervical erector spinae plane block will be administered before the surgery | Other | Block group |
| Intravenous morphine patient controlled analgesia device24 hour morphine consumption will be recorded | Device | Block group, Control group |
Primary outcome
Morphine consumption
Time frame: 24 hour postoperatively
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
2 secondary outcomes
Numering Rating Scale scores for pain
Time frame: 24 hour
Postoperative nausea and vomiting
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Background: PubMed 31161549Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
- Results publication: PubMed 32321860Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
- 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.
Ilker Ince contact
Alper Kilicaslan, MD, Assoc.Prof principal investigator
Necmettin Erbakan University Meram Medical Faculty
İlker İnce, MD, Assoc.Prof principal investigator
Ataturk University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical erector spinae plane block in people with Postoperative Pain and Shoulder Surgery, run by Konya Necmettin Erbakan Üniversitesi 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 May 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alper Kilicaslan, MD, Assoc.Prof (905053780376, dralperkilicaslan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 24 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04397549, which also lists 2 linked publications.
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 22 May 2020.