Erector Spinae BlockPhase 3NCT06386770
Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block
A Phase 3 study testing Dexmedetomidine Injection [Precedex], Bupivacaine Hydrochloride and Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) in people with Erector Spinae Block and Dexmedetomidine, run by Aswan University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Erector Spinae Block, Dexmedetomidine
- What is being tested?
- Dexmedetomidine Injection [Precedex], Bupivacaine Hydrochloride and Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Mar 2025
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •. kidney exploration surgeries.
- ASA I/II patients.
- BMI <35
Who cannot join
- Getting opioid analgesics prior to surgery.
- Local infections at the site where needle for block is to be inserted.
- ASAIII/IV.
- Pregnancy.
- History of drug addiction or alcohol abuse or a psychiatric illness,
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, Aswan Governorate, 81511
soudy S hammad, +201014761523, soudi.salah@aswu.edu.eg
tarek S hemaida, 01007363190, dr.tarek@aswu.edu.eg
About this study
Official title: Systemic Versus Local Dexamedetomedine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block in Kidney Exploration Surgeries ,A Randomized Controlled Trial
The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.
Read the detailed description
Open Kidney surgeries remain one of the approaches used for those patients are requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain for months following surgery.
Effective treatment of postoperative pain allows early mobilization of the patient, shortens the recovery and discharge time, prevents the development of chronic pain, and increases satisfaction and long-term quality of life.
Current modalities used to manage pain for patients undergoing kidney exploration include oral and parenteral opioid administration, local anesthetic infiltration, and certain neuraxial and regional anesthesia procedures including thoracic epidurals and paravertebral blocks.
The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients, and it is performable with minimal or no sedation in the pre-operative holding area.
Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications.
The local anesthetic drugs have a limited duration of action, so we need to add adjuvants such as opioids, alpha two agonists, neostigmine, or magnesium.
Dexmedetomidine is a potent α2 agonist and is a powerful adjuvant to regional anesthesia and analgesia. It can prolong the duration of the nerve block anesthesia resulting in increased effectiveness of the block in terms of duration, less use of opioids, and shorter hospital stay in the absence of clinically significant side effects (hypotension, nausea, vomiting, and pruritus.
Adding adjuvants to local anesthetics is frequently used to prolong the duration of single-injection regional nerve block.
There have been multiple studies claiming increased effectiveness of use of dexmedetomidine and this has been consolidated in a meta-analysis examining the effectiveness of dexamedetomedine as a peripheral nerve block adjuvant.
- Conditions
- Erector Spinae Block, Dexmedetomidine
- Being tested
- Dexmedetomidine Injection [Precedex], Bupivacaine Hydrochloride, Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)
- Keywords
- Bupivacaine, kidney exploration surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
Group ΙI (group DL): erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexamedetomedine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9% ) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia
Bupivacaine HydrochlorideDrug
.Group Ι Block only (group BO) (control group): erector spinae block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia
Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Drug
Group III (group D IV): erector spinea block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexamedetomedine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group Ι Block only (group BO) (control group) | Active comparator | Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia Receives: Drug: Bupivacaine Hydrochloride |
| Group ΙI (group DL): | Active comparator | Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexmedetomidine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9%) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia Receives: Drug: Dexmedetomidine Injection [Precedex] |
| Group III (group D IV): | Active comparator | Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexmedetomidine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia Receives: Drug: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.
The duration of analgesia, this was defined as the time in minutes to the first request for
Measured: at 60 , 180 minutes
Secondary outcomes (4)
2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period .
- Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period.
Measured: at 1, 3, 6, 12, 24, 36 and 48 hours
Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed
amsay Sedation Scale (RSS) The RSS is a user-friendly and therefore commonly used sedation scale, with scores ranging from +4 (a violent dangerous patient) to -5 (an unarousable patient).6 A sedation score of 0 is most often therapeutically targeted, as it correlates with an alert and calm patient.
Measured: at 1, 3, 6, 12, 24, 36 and 48 hours
Intraoperative hemodynamic parameters blood pressure
blood pressure measurement obtained by non-invasive blood pressure cuff during intraoperative and postoperative in PACU expressed in mmhg
Measured: at 1, 3, 6, hours
Minimum alveolar concentration (MAC) requirements
Minimum alveolar concentration or MAC is the concentration, often expressed as a percentage by volume, of a vapour in the alveoli of the lungs that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus.
Measured: during intraoperative periods expressed in minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jun 2024
- Primary completion25 Feb 2025 (estimated)
- Study completion1 Mar 2025 (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 Erector Spinae BlockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soudy Salah Hammad, Aswan University
- Investigators
- Rehab A Mahmoud, MSc, Study chair, Aswan UniversityAyman M Eldemrdash, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386770
- Sponsor's protocol ID
- Asw.U./742 /2/23
- Status last verified
- May 2024
- First submitted
- 4 Apr 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Wang Q, Li H, Wei S, Zhang G, Ni C, Sun L, Zheng H. Dexmedetomidine Added to Ropivacaine for Ultrasound-guided Erector Spinae Plane Block Prolongs Analgesia Duration and Reduces Perioperative Opioid Consumption After Thoracotomy: A Randomized, Controlled Clinical Study. Clin J Pain. 2021 Oct 12;38(1):8-14. doi: 10.1097/AJP.0000000000000992.
PubMed 34636753
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Versus Local Dexamedetomedine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block in Kidney Exploration Surgeries ,A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06386770
- Acronym / sponsor ID
- Asw.U./742 /2/23
- Conditions
- Erector Spinae Block, Dexmedetomidine
- Keywords
- Bupivacaine, kidney exploration surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Apr 2024 (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 investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.
Detailed description
Open Kidney surgeries remain one of the approaches used for those patients are requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain for months following surgery.
Effective treatment of postoperative pain allows early mobilization of the patient, shortens the recovery and discharge time, prevents the development of chronic pain, and increases satisfaction and long-term quality of life.
Current modalities used to manage pain for patients undergoing kidney exploration include oral and parenteral opioid administration, local anesthetic infiltration, and certain neuraxial and regional anesthesia procedures including thoracic epidurals and paravertebral blocks.
The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients, and it is performable with minimal or no sedation in the pre-operative holding area.
Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications.
The local anesthetic drugs have a limited duration of action, so we need to add adjuvants such as opioids, alpha two agonists, neostigmine, or magnesium.
Dexmedetomidine is a potent α2 agonist and is a powerful adjuvant to regional anesthesia and analgesia. It can prolong the duration of the nerve block anesthesia resulting in increased effectiveness of the block in terms of duration, less use of opioids, and shorter hospital stay in the absence of clinically significant side effects (hypotension, nausea, vomiting, and pruritus.
Adding adjuvants to local anesthetics is frequently used to prolong the duration of single-injection regional nerve block.
There have been multiple studies claiming increased effectiveness of use of dexmedetomidine and this has been consolidated in a meta-analysis examining the effectiveness of dexamedetomedine as a peripheral nerve block adjuvant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries
| Arm | Type | Receives |
|---|---|---|
| Group Ι Block only (group BO) (control group) | Active comparator | Drug: Bupivacaine HydrochlorideUltrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia |
| Group ΙI (group DL): | Active comparator | Drug: Dexmedetomidine Injection [Precedex]Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexmedetomidine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9%) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia |
| Group III (group D IV): | Active comparator | Drug: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexmedetomidine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- •. kidney exploration surgeries.
- ASA I/II patients.
- BMI <35
Key exclusion criteria (5 listed)
- Getting opioid analgesics prior to surgery.
- Local infections at the site where needle for block is to be inserted.
- ASAIII/IV.
- Pregnancy.
- History of drug addiction or alcohol abuse or a psychiatric illness,
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 |
|---|---|---|
| Dexmedetomidine Injection [Precedex]Group ΙI (group DL): erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexamedetomedine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9% ) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia | Drug | Group ΙI (group DL): |
| Bupivacaine Hydrochloride.Group Ι Block only (group BO) (control group): erector spinae block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia | Drug | Group Ι Block only (group BO) (control group) |
| Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Group III (group D IV): erector spinea block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexamedetomedine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia. | Drug | Group III (group D IV): |
Primary outcome
The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.
Time frame: at 60 , 180 minutes
The duration of analgesia, this was defined as the time in minutes to the first request for
4 secondary outcomes
2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period .
Time frame: at 1, 3, 6, 12, 24, 36 and 48 hours
Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed
Time frame: at 1, 3, 6, 12, 24, 36 and 48 hours
Intraoperative hemodynamic parameters blood pressure
Time frame: at 1, 3, 6, hours
Minimum alveolar concentration (MAC) requirements
Time frame: during intraoperative periods expressed in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 34636753Wang Q, Li H, Wei S, Zhang G, Ni C, Sun L, Zheng H. Dexmedetomidine Added to Ropivacaine for Ultrasound-guided Erector Spinae Plane Block Prolongs Analgesia Duration and Reduces Perioperative Opioid Consumption After Thoracotomy: A Randomized, Controlled Clinical Study. Clin J Pain. 2021 Oct 12;38(1):8-14. doi: 10.1097/AJP.0000000000000992.
- Individual participant dataSharing planned: No
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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.
Rehab A Mahmoud, MSc study chair
Aswan University
Ayman M Eldemrdash principal investigator
Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine Injection [Precedex], Bupivacaine Hydrochloride and Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) in people with Erector Spinae Block and Dexmedetomidine, run by Aswan 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 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 21 Feb 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tarek s Hemaida, MD (0100 736 3190, dr.tarek@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics. (time frame: at 60 , 180 minutes). 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 NCT06386770, 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 21 Feb 2025.