ArthroscopyNCT05165836
Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy
A study testing Erector Spinae Plane block without Dexmedetomidine group and Erector Spinae Plane block with Dexmedetomidine group in people with Arthroscopy and Erector Spinae Plane Block, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthroscopy, Erector Spinae Plane Block, Analgesia
- What is being tested?
- Erector Spinae Plane block without Dexmedetomidine group and Erector Spinae Plane block with Dexmedetomidine group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2021to 1 Aug 2022
- 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 aged 18-65 years
- Both genders and BMI < 40 kg/m2
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients who are posted for elective shoulder arthroscopy
Who cannot join
- Known allergy to local anesthetics
- Allergy to all opioid medications
- Diagnostic shoulder arthroscopic procedures,
- Patients with chronic opioid use and coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia After Shoulder Arthroscopy: A Randomized Controlled Study
The aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy.
Read the detailed description
Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.
There are many postoperative pain management modalities after shoulder arthroscopy including non-steroidal anti-inflammatory drugs, intraarticular injection, regional nerve blocks, patient controlled analgesia and cryotherapy.
The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies , percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty .
ESPB has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.
Dexmedetomidine is a very selective α2 adrenoceptor agonist that is tenfold more selective than clonidine. It is a highly flexible medication in anesthetic practice, finding use in an expanding range of clinical circumstances.
- Conditions
- Arthroscopy, Erector Spinae Plane Block, Analgesia
- Being tested
- Erector Spinae Plane block without Dexmedetomidine group, Erector Spinae Plane block with Dexmedetomidine group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane block without Dexmedetomidine groupProcedure or surgery
Block will be performed with an ultrasound machine (Philips CX50 Extreme edition). A 2-5 MH2 curved probe will be positioned transversely to visualize the lateral tip of thoracic vertebrae2 transverse Process. Before surgery with patients in sitting position, the transducer will be positioned longitudinally 3 cm lateral to the thoracic vertebrae2 spinous process. The trapezius, rhomboid major, and erector spinae muscles will be revealed superficial to the shadow of the hyperechoic transverse process. Then, 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 19 ml of bupivacaine 0.25% + 1 mL saline will be injected. The needle tip's placement will be confirmed by observable fluid spread lifting the erector spinae muscle away from the transverse process's bony shadow.
Erector Spinae Plane block with Dexmedetomidine groupProcedure or surgery
Block will be performed with an ultrasound machine (Philips CX50 Extreme edition). A 2-5 MH2 curved probe will be positioned transversely to visualize the lateral tip of thoracic vertebrae2 transverse Process. Before surgery with patients in sitting position, the transducer will be positioned longitudinally 3 cm lateral to the thoracic vertebrae2 spinous process. The trapezius, rhomboid major, and erector spinae muscles will be revealed superficial to the shadow of the hyperechoic transverse process. Then, 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg will be injected. The needle tip's placement will be confirmed by observable fluid spread lifting the erector spinae muscle away from the transverse process's bony shadow.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane block without Dexmedetomidine group | Placebo comparator | Patients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL saline Receives: Procedure: Erector Spinae Plane block without Dexmedetomidine group |
| Erector Spinae Plane block with Dexmedetomidine group | Experimental | Patients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg Receives: Procedure: Erector Spinae Plane block with Dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Rescue analgesia in the form of 3 mg IV morphine (mg) will be given if the numeric rating scale (NRS) score is ≥ 4 repeated with 10 minutes lockout interval till the numeric rating scale (NRS) score becomes less than 3
Measured: 24 hours postoperative
Secondary outcomes (2)
Post-operative pain score
After extubation, patients will be evaluated for pain using a numeric rating scale (NRS) score at 0,3,6,12,24 h for pain that ranged from (0 = no pain) to (10 = the worst imaginable pain). If the score is ≥ 4, rescue analgesia will be given in the form of fentanyl in a dose of 0.5µg/kg by iv route.
Measured: 24 hours Postoperative
Time to first request of rescue analgesia
Time to the first rescue analgesic request (min) will be also recorded.
Measured: 24 hours Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start25 Dec 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthroscopyStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fouad Algyar, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165836
- Sponsor's protocol ID
- MKSU 40-11-21
- Status last verified
- Sep 2022
- First submitted
- 7 Dec 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The supporting data will be available upon a reasonable request from the corresponding author
Publications
Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.
PubMed 36793000
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia After Shoulder Arthroscopy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05165836
- Acronym / sponsor ID
- MKSU 40-11-21
- Conditions
- Arthroscopy, Erector Spinae Plane Block, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 21 Dec 2021 (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 aim of this study is to evaluate the effect of adding dexmedetomidine as an adjuvant to bupivacaine in ultrasound (US) guided erector spinae plane block (ESPB) for managing acute postoperative pain in patients undergoing shoulder arthroscopy.
Detailed description
Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.
There are many postoperative pain management modalities after shoulder arthroscopy including non-steroidal anti-inflammatory drugs, intraarticular injection, regional nerve blocks, patient controlled analgesia and cryotherapy.
The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB has been used successfully in many surgeries such as mastectomy, thoracotomies , percutaneous nephrolithotomies, lumbar fusions, hernia repair, cesarean delivery and even in total hip arthroplasty .
ESPB has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.
Dexmedetomidine is a very selective α2 adrenoceptor agonist that is tenfold more selective than clonidine. It is a highly flexible medication in anesthetic practice, finding use in an expanding range of clinical circumstances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane block without Dexmedetomidine group | Placebo comparator | Procedure: Erector Spinae Plane block without Dexmedetomidine groupPatients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL saline |
| Erector Spinae Plane block with Dexmedetomidine group | Experimental | Procedure: Erector Spinae Plane block with Dexmedetomidine groupPatients received Ultrasound-guided Erector Spinae Plane block at T2 using 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65 years
- Both genders and BMI < 40 kg/m2
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients who are posted for elective shoulder arthroscopy
Key exclusion criteria (4 listed)
- Known allergy to local anesthetics
- Allergy to all opioid medications
- Diagnostic shoulder arthroscopic procedures,
- Patients with chronic opioid use and coagulopathy
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 |
|---|---|---|
| Erector Spinae Plane block without Dexmedetomidine groupBlock will be performed with an ultrasound machine (Philips CX50 Extreme edition). A 2-5 MH2 curved probe will be positioned transversely to visualize the lateral tip of thoracic vertebrae2 transverse Process. Before surgery with patients in sitting position, the transducer will be positioned longitudinally 3 cm lateral to the thoracic vertebrae2 spinous process. The trapezius, rhomboid major, and erector spinae muscles will be revealed superficial to the shadow of the hyperechoic transverse process. Then, 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 19 ml of bupivacaine 0.25% + 1 mL saline will be injected. The needle tip's placement will be confirmed by observable fluid spread lifting the erector spinae muscle away from the transverse process's bony shadow. | Procedure or surgery | Erector Spinae Plane block without Dexmedetomidine group |
| Erector Spinae Plane block with Dexmedetomidine groupBlock will be performed with an ultrasound machine (Philips CX50 Extreme edition). A 2-5 MH2 curved probe will be positioned transversely to visualize the lateral tip of thoracic vertebrae2 transverse Process. Before surgery with patients in sitting position, the transducer will be positioned longitudinally 3 cm lateral to the thoracic vertebrae2 spinous process. The trapezius, rhomboid major, and erector spinae muscles will be revealed superficial to the shadow of the hyperechoic transverse process. Then, 3ml lidocaine 2% will be used to anesthetize the skin. Using a 20-gauge block needle put in-plane in a cephalad-to-caudad orientation to position the tip into the fascial plane on the deep (anterior) side of the erector spinae muscle, 19 ml of bupivacaine 0.25% + 1 mL dexmedetomidine 0.5 µg/kg will be injected. The needle tip's placement will be confirmed by observable fluid spread lifting the erector spinae muscle away from the transverse process's bony shadow. | Procedure or surgery | Erector Spinae Plane block with Dexmedetomidine group |
Primary outcome
The total rescue morphine (mg) consumption in the first 24 post-operative hours.
Time frame: 24 hours postoperative
Rescue analgesia in the form of 3 mg IV morphine (mg) will be given if the numeric rating scale (NRS) score is ≥ 4 repeated with 10 minutes lockout interval till the numeric rating scale (NRS) score becomes less than 3
2 secondary outcomes
Post-operative pain score
Time frame: 24 hours Postoperative
Time to first request of rescue analgesia
Time frame: 24 hours Postoperative
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 13 Sep 2022.
- Derived from this study: PubMed 36793000Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.
- Individual participant dataSharing planned: Yes. The supporting data will be available upon a reasonable request from the corresponding author
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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 Erector Spinae Plane block without Dexmedetomidine group and Erector Spinae Plane block with Dexmedetomidine group in people with Arthroscopy and Erector Spinae Plane Block, run by Kafrelsheikh University at 1 site in Egypt.
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 4 inclusion and 4 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 13 Sep 2022. 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 Egypt. 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?
The total rescue morphine (mg) consumption in the first 24 post-operative hours. (time frame: 24 hours postoperative). 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 NCT05165836, which also lists 1 linked publication.
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 13 Sep 2022.