Axillary Brachial Plexus BlockNCT05466500
The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries
A study testing Ultrasound guided axillary block with intravenous dexamethasone and Ultrasound guided axillary block in people with Axillary Brachial Plexus Block, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management. Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be… Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Axillary Brachial Plexus Block
- What is being tested?
- Ultrasound guided axillary block with intravenous dexamethasone and Ultrasound guided axillary block
- Type of treatment
- Injection or infusion, 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
- 26 Jul 2022to Dec 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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gender both males and females
- ASA ClassI-II
- Age 4-14 years
- Patients under going upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa
Who cannot join
- Parent refusal.
- Patients with apparent infection at site of needle insertion.
- Patients with any coagulation disorder(Platelets ≤ 50,000 and/or INR> 1.5)
- Patients with known neuropathy or brachial plexus injury.
- Patient with known sensitivity to local anesthetic drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy, Cairo University
Cairo
Ahmed nabih, lecturer, 01002773488 ext. 202, nabihomar100@yahoo.com
Abdelmoneim adel, lecturer, 01004392046 ext. 202, Abdelmonemadel87@gmail.com
About this study
Official title: The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries: A Randomized Control Trial
Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management.
Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa.Sensory blockade of the brachial plexus for perioperative analgesia leads to stable haemodynamics intraoperatively, smoother emergence from general anaesthesia and decreased need for supplemental analgesics or suppositories in the Post-operative period Intravenous (IV) dexamethasone has been used as an additive to local anesthetic for peripheral nerve blocks (PNBs) in adults with variable efficacy.To the best of our knowledge the efficacy of intravenous dexamethasone as adjuvant to bupivacaine in ultrasound guided axillary brachial plexus block in pediatrics has not been investigated
Read more
In this study the investigators will assess the analgesic effect of adding intravenous dexamethasone to bupivacaine in ultrasound guided axillary block in children undergoing upper limb orthopedic surgeries.
Objectives:
- To determine the effect of adding intravenous dexamethasone on the duration of analgesia .
- To determine the effect of adding intravenousdexamethasone on quality of analgesia
Read the detailed description
This a randomized control trial is designed to include (60) patients ASA physical statusI-II patients ranging from(4) to(14)years old scheduled for upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa.
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group A :Axillary block with 2 mg/kg of 0.25% bupivacaine. (n=30) Group B: Axillary block with 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous:(n=30)
All children will be anaesthetized in accordance with the local policy of the Abu El-Reesh pediatric hospital-Cairo university's pediatric anaesthetic unit. Except for oral clear liquids intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, as well as their age and body weight will be recorded. Pre medicated by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg before insertion of intravenous (I.V) cannula.On arriving the operating room, heart rate (HR) ,oxygen saturation and non-invasive blood pressure will be continuously recorded, using standard monitor (Dräger infinity vista XL).
All patients will be induced with propofol 2 mg / kg , atracurium 0.5mg/kg and fentanyl 1μg/kg, then the patients will be intubated by appropriate size of endotracheal tube volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, with the goal of keeping the BIS measurement between (40-60), and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.Then the block will be conducted after general anesthesia by an expert anesthesiologist who is different from the anesthesiologist who provided anesthesia to the patient.
Axillary block
Axillary nerve block will be induced with patient in supine under GA with ultrasound SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 MHz linear array).The probe will be protected with sterile cover, antiseptic betadine will be applied to the site of block injection , the operating arm will be abducted by 70 externally rotated, and the elbow will be flexed to ~90. Within the axillary crease the probe position will be placed sagittal where bounded by the pectoralis major antero-medially and the latissimus dorsi and teres major posteromedial.
The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. The block will be applied by 50-mm block needle 22 gauge at cephalic side of the probe. The same volume of local anesthetic will be used in each group with 2 mg/kg of 0.25% bupivacaine. Group A will receive 2ml of saline solution i.v after completing the block,Group B will receive 0.1mg/kg dexamethasone i.v after completing the block.
The time passed between the entrance of the needle into the skin and the injection's completion is referred to as axillary block performance time.The end of the local anesthetic solution injection will be considered the time zero to assess the blockade effectiveness. The surgical procedure will be start after 15-20 min.
If there is an increase in heart rate or mean arterial blood pressure of more than 20% of the baseline value after skin incision then it will be considered asblock failure and these patients will be excluded from the study. 1-2ug/kg intravenous fentanyl will be given to failed block. At the end of surgery,residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg. All patients will receive 15mg/kg paracetamol IV every 6 hours.
Postoperative
- The postoperative pain assessment in the PACU and the wardwill be performed using a (FLACC score)(APPENDIX 1)(10).Patients will be assessed immediately postoperatively and then at 1st, 4th, 8th, 12th , 24 hour post-operatively.Patients with pain score more than 3\10 ,Pethidine I.V will be given as rescue analgesic (1 mg/kg) when needed.The time to first request of postoperative analgesic is defined as( the time interval from LA injection to first dose of pethidine adminstration) will be recorded. The total amount of pethidine in the first postoperative 24 hours will be calculated in both groups.
- Block related complications will be recorded such as failed block, local anaesthetic toxicity, vascular puncture, paresthesia.
Measurement tools
- Patients demographic data will be collected; age, gender, height,weight , type and duration of surgery
- Block time duration, Surgical procedure , duration and Axillary block performance time.
- Intraoperative haemodynamic (Heart rate ,systolic and diastolic blood pressure)pre-induction , post-intubation , post-block , immediate post skin incision , every 15 minutes.
- Postoperative pain assessments using(FLACC score)at at 0 point 1hr, 4hr, 8hr ,12 hr, and at 24 hr
- Time to first request of rescue postoperative analgesic
- Total opioid consumption in 24h postoperative
- Tourniquet whether used or not and if used time and pressure will be recorded
- Conditions
- Axillary Brachial Plexus Block
- Being tested
- Ultrasound guided axillary block with intravenous dexamethasone, Ultrasound guided axillary block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided axillary block with intravenous dexamethasoneProcedure or surgery
Also called peripheral nerve block with dexamethasone, bupivacaine and dexamethasone intravenous
it will be given by one researcher using 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous
Ultrasound guided axillary blockProcedure or surgery
Also called peripheral nerve block, bupivacaine only
it will be given by one researcher using 2 mg/kg of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided axillary block with intravenous dexamethasone | Active comparator | The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked and use of intravenous dexamethasone as an adjuvant to bupivacaine for Post-operative analgesia following sensory blockade of the axillary brachial plexus in paediatrics undergoing below elbow orthopaedic surgeries. Receives: Procedure: Ultrasound guided axillary block with intravenous dexamethasone |
| Ultrasound guided axillary block | Placebo comparator | The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identifythe hyperechoic median, ulnar, and radial nervesin relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked Receives: Procedure: Ultrasound guided axillary block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first request of opioid analgesia
Time to first request of opioid analgesia will be"the time interval between LA injection and the first request to postoperative analgesia (first dose of pethidine adminstration)" (minutes)
Measured: it will be measured in the first 24 hours postoperative
Secondary outcomes (1)
Total opioid consumption 24 hours postoperative
Total opioid consumption will be consumed in the first 24 hours postoperative
Measured: It will be measured in the first 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 posted20 Jul 2022
- Study start26 Jul 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary Brachial Plexus 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed nabih youssef, Kasr El Aini Hospital
- Investigators
- Ahmed nabih, lecturer, Principal investigator, Anesthesia department , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466500
- Sponsor's protocol ID
- N-53-2022
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05466500
- Acronym / sponsor ID
- N-53-2022
- Conditions
- Axillary Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 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.
Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management.
Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa.Sensory blockade of the brachial plexus for perioperative analgesia leads to stable haemodynamics intraoperatively, smoother emergence from general anaesthesia and decreased need for supplemental analgesics or suppositories in the Post-operative period Intravenous (IV) dexamethasone has been used as an additive to local anesthetic for peripheral nerve blocks (PNBs) in adults with variable efficacy.To the best of our knowledge the efficacy of intravenous dexamethasone as adjuvant to bupivacaine in ultrasound guided axillary brachial plexus block in pediatrics has not been investigated
In this study the investigators will assess the analgesic effect of adding intravenous dexamethasone to bupivacaine in ultrasound guided axillary block in children undergoing upper limb orthopedic surgeries.
Objectives:
- To determine the effect of adding intravenous dexamethasone on the duration of analgesia .
- To determine the effect of adding intravenousdexamethasone on quality of analgesia
Detailed description
This a randomized control trial is designed to include (60) patients ASA physical statusI-II patients ranging from(4) to(14)years old scheduled for upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa.
Patients meeting the inclusion criteria will be randomly assigned to receive either :
Group A :Axillary block with 2 mg/kg of 0.25% bupivacaine. (n=30) Group B: Axillary block with 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous:(n=30)
All children will be anaesthetized in accordance with the local policy of the Abu El-Reesh pediatric hospital-Cairo university's pediatric anaesthetic unit. Except for oral clear liquids intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, as well as their age and body weight will be recorded. Pre medicated by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg before insertion of intravenous (I.V) cannula.On arriving the operating room, heart rate (HR) ,oxygen saturation and non-invasive blood pressure will be continuously recorded, using standard monitor (Dräger infinity vista XL).
All patients will be induced with propofol 2 mg / kg , atracurium 0.5mg/kg and fentanyl 1μg/kg, then the patients will be intubated by appropriate size of endotracheal tube volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, with the goal of keeping the BIS measurement between (40-60), and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.Then the block will be conducted after general anesthesia by an expert anesthesiologist who is different from the anesthesiologist who provided anesthesia to the patient.
Axillary block
Axillary nerve block will be induced with patient in supine under GA with ultrasound SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 MHz linear array).The probe will be protected with sterile cover, antiseptic betadine will be applied to the site of block injection , the operating arm will be abducted by 70 externally rotated, and the elbow will be flexed to ~90. Within the axillary crease the probe position will be placed sagittal where bounded by the pectoralis major antero-medially and the latissimus dorsi and teres major posteromedial.
The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. The block will be applied by 50-mm block needle 22 gauge at cephalic side of the probe. The same volume of local anesthetic will be used in each group with 2 mg/kg of 0.25% bupivacaine. Group A will receive 2ml of saline solution i.v after completing the block,Group B will receive 0.1mg/kg dexamethasone i.v after completing the block.
The time passed between the entrance of the needle into the skin and the injection's completion is referred to as axillary block performance time.The end of the local anesthetic solution injection will be considered the time zero to assess the blockade effectiveness. The surgical procedure will be start after 15-20 min.
If there is an increase in heart rate or mean arterial blood pressure of more than 20% of the baseline value after skin incision then it will be considered asblock failure and these patients will be excluded from the study. 1-2ug/kg intravenous fentanyl will be given to failed block. At the end of surgery,residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg. All patients will receive 15mg/kg paracetamol IV every 6 hours.
Postoperative
- The postoperative pain assessment in the PACU and the wardwill be performed using a (FLACC score)(APPENDIX 1)(10).Patients will be assessed immediately postoperatively and then at 1st, 4th, 8th, 12th , 24 hour post-operatively.Patients with pain score more than 3\10 ,Pethidine I.V will be given as rescue analgesic (1 mg/kg) when needed.The time to first request of postoperative analgesic is defined as( the time interval from LA injection to first dose of pethidine adminstration) will be recorded. The total amount of pethidine in the first postoperative 24 hours will be calculated in both groups.
- Block related complications will be recorded such as failed block, local anaesthetic toxicity, vascular puncture, paresthesia.
Measurement tools
- Patients demographic data will be collected; age, gender, height,weight , type and duration of surgery
- Block time duration, Surgical procedure , duration and Axillary block performance time.
- Intraoperative haemodynamic (Heart rate ,systolic and diastolic blood pressure)pre-induction , post-intubation , post-block , immediate post skin incision , every 15 minutes.
- Postoperative pain assessments using(FLACC score)at at 0 point 1hr, 4hr, 8hr ,12 hr, and at 24 hr
- Time to first request of rescue postoperative analgesic
- Total opioid consumption in 24h postoperative
- Tourniquet whether used or not and if used time and pressure will be recorded
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided axillary block with intravenous dexamethasone | Active comparator | Procedure: Ultrasound guided axillary block with intravenous dexamethasoneThe probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked and use of intravenous dexamethasone as an adjuvant to bupivacaine for Post-operative analgesia following sensory blockade of the axillary brachial plexus in paediatrics undergoing below elbow orthopaedic surgeries. |
| Ultrasound guided axillary block | Placebo comparator | Procedure: Ultrasound guided axillary blockThe probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identifythe hyperechoic median, ulnar, and radial nervesin relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gender both males and females
- ASA ClassI-II
- Age 4-14 years
- Patients under going upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa
Key exclusion criteria (5 listed)
- Parent refusal.
- Patients with apparent infection at site of needle insertion.
- Patients with any coagulation disorder(Platelets ≤ 50,000 and/or INR> 1.5)
- Patients with known neuropathy or brachial plexus injury.
- Patient with known sensitivity to local anesthetic drugs
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 |
|---|---|---|
| Ultrasound guided axillary block with intravenous dexamethasoneAlso: peripheral nerve block with dexamethasone, bupivacaine and dexamethasone intravenousit will be given by one researcher using 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous | Procedure or surgery | Ultrasound guided axillary block with intravenous dexamethasone |
| Ultrasound guided axillary blockAlso: peripheral nerve block, bupivacaine onlyit will be given by one researcher using 2 mg/kg of 0.25% bupivacaine | Procedure or surgery | Ultrasound guided axillary block |
Primary outcome
Time to first request of opioid analgesia
Time frame: it will be measured in the first 24 hours postoperative
Time to first request of opioid analgesia will be"the time interval between LA injection and the first request to postoperative analgesia (first dose of pethidine adminstration)" (minutes)
1 secondary outcome
Total opioid consumption 24 hours postoperative
Time frame: It will be measured in the first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- 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.
Ahmed nabih, lecturer principal investigator
Anesthesia department , Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided axillary block with intravenous dexamethasone and Ultrasound guided axillary block in people with Axillary Brachial Plexus Block, run by Kasr El Aini Hospital 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 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 27 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed nabih, lecturer (01002773488 ext. 202, nabihomar100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first request of opioid analgesia (time frame: it will be measured in the first 24 hours postoperative). 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 27 Jul 2022.