Pediatric ThoracoscopyNCT04688918
Retrolaminar Block for Pediatric Thoracoscopic Sympathectomy
A study testing Retrolaminar block and paravertebral group in people with Pediatric Thoracoscopy, run by Mansoura University at 1 site in Egypt.
Trial summary
Thoracoscopic sympathectomy is a rapid and simple technique associated with rare complications, but it is associated with severe postoperative pain that makes breathing and coughing difficult resulting in increased occurrence of pulmonary complications. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Thoracoscopy
- What is being tested?
- Retrolaminar block and paravertebral group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2021to 20 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) status: 1 or 2
- thoracoscopic sympathectomy
Who cannot join
- history of clinically significant cardiac, hepatic, renal, or neurological dysfunction
- coagulopathy
- known allergy to amide local anesthetics
- local infection at injection sites
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
Sameh M El-Sherbiny, MD, +201006500748, Smfsherbiny@yahoo.com
Sameh M El-Sherbiny, MD
About this study
Official title: Ultrasound-guided Retrolaminar Block Versus Paravertebral Block for Postoperative Analgesia in Children Undergoing Thoracoscopic Sympathectomy: a Non-inferiority Study
Thoracoscopic sympathectomy is a rapid and simple technique associated with rare complications, but it is associated with severe postoperative pain that makes breathing and coughing difficult resulting in increased occurrence of pulmonary complications. Paravertebral block has frequently been performed for this procedure but its technical difficulty and safety profile may represent a limitation of its routine use. This prospective, randomized, double-blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound-guided thoracic retrolaminar block (TRLB) with the paravertebral block in children undergoing thoracoscopic sympathectomy. We hypothesize that ultrasound-guided thoracic retrolaminar block may comparable analgesic effect to paravertebral block with a lesser incidence of complications in pediatric patients undergoing thoracoscopic sympathectomy.
Read the detailed description
Thoracoscopic sympathectomy is a rapid and simple technique associated with rare complications, but it is associated with severe postoperative pain that makes breathing and coughing difficult resulting in increased occurrence of pulmonary complications, need for analgesic, and hospital stays. Postoperative pain control for pediatric surgeries is a major issue and affects the quality of recovery, parental satisfaction, and surgical success. Opioid usage for pediatric analgesia has many disadvantages, such as postoperative vomiting, pruritus, respiratory depression, and sedation. The introduction of anatomy-based ultrasound (US) imaging for facilitating nerve localization is a major advancement in the field of pediatric regional anesthesia. Paravertebral block has frequently been performed for this procedure but its technical difficulty and safety profile may represent a limitation of its routine use. Ultrasound-guided retrolaminar block (RLB) is a newer alternative to PV block where LA is injected between the lamina and deep paraspinal muscle, rather than between the parietal pleura and costotransverse ligament. This makes it both technically less difficult, but also at less risk of causing substantial side effects such as pneumothorax, inadvertent intrathecal injection, and neurological injury. The analgesic efficacy of RLB has been proven in adults after breast surgery, in patients with multiple rib fractures, and after acute lumbar trauma. This prospective, randomized, double-blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound-guided thoracic retrolaminar block (TRLB) with the paravertebral block in children undergoing thoracoscopic sympathectomy. We hypothesize that ultrasound-guided thoracic retrolaminar block may comparable analgesic effect to paravertebral block with a lesser incidence of complications in pediatric patients undergoing thoracoscopic sympathectomy. The study will be carried out in Mansoura university children's hospital (MUCH) after obtaining approval from Mansoura Faculty of Medicine Institutional Research Board. Informed written consent will be obtained from the patient guardians'. The planned duration of this study is 8 months. The time gap of the study will be from January 2021 to August 2020.
Eighty children of the American Society of Anesthesiologists physical status I-II of either sex with their age ranging from 8 to 18 years undergoing thoracoscopic surgeries will be recruited for the study.Exclusion criteria will include the history of clinically significant cardiac, hepatic, renal, or neurological dysfunction, coagulopathy, known allergy to amide local anesthetics, and local infection at injection sites.General anesthesia will be induced with incremental sevoflurane in 100% oxygen. After reaching an adequate depth of anesthesia, venous access was established, and then vecuronium will be given in a dose of 0.6 mg/kg and ETT will be inserted. Anesthesia was maintained under controlled ventilation with 1-1.5 MAC of isoflurane and 0.1 mg/kg vecuronium every 30 minutes as a muscle relaxant. Standard intraoperative monitors will be applied for measurement of ECG, heart rate, pulse oximetry, noninvasive blood pressure, and end-tidal carbon dioxide concentration. Baseline readings will be recorded.Computer-generated random numbering of the studied patients will be used for patient randomization before surgery. An opaque sealed envelope will be used and opened in the operative theatre by an anesthesiologist who will not be involved in the current study and who will prepare the drugs used in the study. The anesthesiologist who will be responsible for the patient and the nurse who recorded the patient data will be unaware of the patient's group. Patients will be randomly allocated to one of two equal groups (40 patients for each). Control group (n=40): the patients will receive paravertebral. block.TRLB block group (n=40): ultrasound-guided thoracic retrolaminar block (TRLB).All blocks will be performed by the same anesthetist who is experienced in US-guided pediatric nerve blocks. A high-resolution linear probe with a sterile cover will be used to perform the block. All surgical procedures will be performed by the same surgical team.All blocks will be performed by the same anesthetist who is experienced in US-guided pediatric nerve blocks... All surgical procedures will be performed by the same surgical team.The patient will be placed in a prone position with a pillow under the chest. The spinous process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high-frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vertebral lamina. An 80 mm 22-gauge needle will be inserted in an in-plane technique from cranial to the caudal direction and will be advanced till hitting the laminae of the fourth thoracic vertebrae and then we will try to inject the local anesthetic between the lamina and deep paraspinal muscle in RLB group and between the parietal pleura and costotransverse ligament in the paravertebral group. . Bupivacaine 0.25%, 0.4mL/kg will be injected. Vital signs will be recorded every 5 min after the block to ensure the adequacy of the blockade, especially after surgical incision. Surgical procedures will be allowed to start 15 min after the performance of the block. In case of an increase in either patient heart rate to more than 20% of the baseline, fentanyl at 1 ug/kg will be administered. More than 30% decrease in heart rate and systolic blood pressure, respectively, as compared with the baseline values will be treated with atropine or ephedrine as appropriate but the postoperative data of those patients will not be included in the statistical analysis.After completion of the surgery, children will be transferred to the post-anesthesia care unit (PACU) for continuous monitoring of vital signs and for pain assessment. Children will be monitored every 15 min during the first hour in the PACU and every 30 min in the daycare unit until discharge from the hospital. Postoperative analgesia will be measured using vas score 0, 1, 2, 4, 6, 12, 18, 24 hours after surgery. Patients with vas>3 will be given rescue analgesia with 0.05mg/kg morphine intravenously. The primary outcome measure is the total morphine consumption in the first postoperative 24 h. The secondary outcome measures are Postoperative pain score, Time to first rescue analgesia and its frequency, Parent's satisfaction. Block-related complications (pneumothorax, local anesthetic toxicity, or hematoma) and frequency of Nausea and vomiting. Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. The distribution of data will be first tested by the Shapiro test. Data will be presented as mean and standard deviation (SD), median, and range of numbers and percentages. For normally distributed data, an unpaired t-test will be used to compare between mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P-value ≤ of 0.05 will be considered as the level of statistical significance.
- Conditions
- Pediatric Thoracoscopy
- Being tested
- Retrolaminar block, paravertebral group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar blockProcedure or surgery
A high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The spinous process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vertebral lamina. A 50 mm 22-gauge needle will be inserted in an in-plane technique from cranial to caudal direction and will be advanced till hitting the laminae of fourth thoracic vertebrae and then we will try to inject the local anesthetic, if the resistance to injection is very high, hence we will withdraw the needle slowly and its tip will be kept in its position immediately after disappearance this high resistance. Bupivacaine 0.25%, 0.4mL/kg will be injected.
paravertebral groupProcedure or surgery
A high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The transverse process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vcostotransverse ligament, 0.4mL/kg will be injected
| Study group | Role | What they receive |
|---|---|---|
| Group A (Retrolamianar block(RLB)) | Active comparator | Ultrasound-guided RLB with injection of 0.4ml/kglocal anesthestic (bupivacaine) 0.25%will be performed under strict aseptic precautions with ultrasound guidance with patient in the prone position. Receives: Procedure: Retrolaminar block |
| Paravertebral group | Active comparator | Ultrasound-guided paravertebral injection of 0.4ml/kg saline 0.9% will be performed under strict aseptic precautions under ultrasound guidance with patient in the prone position. Receives: Procedure: paravertebral group |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
The total dose of morphine consumed in first 24 hours will be recorded (mg)
Measured: Up to 24 hours after the procedure
Secondary outcomes (4)
pain score
Pain levels will be assessed post operatively using visual analogue scale(vas),usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]),vas measured at 0,1, 2, 4, 6, 12, 24 hours
Measured: Up to 24 hours after the procedure
number of patients who will need analgesia
number of patients who request analgesia in the postoperative period
Measured: Up to 24 hours after the procedure
Block related complications
Block related complications (pneumothorax, local anesthetic toxicity or hematoma).[
Measured: Up to 24 hours after the procedure
time of first analgesic request (min)
the time of first analgesic request in first 24 hours
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start3 Jan 2021
- Primary completion15 Nov 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ThoracoscopyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Prospective, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Alseoudy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688918
- Sponsor's protocol ID
- R.20.12.1115
- Status last verified
- Mar 2023
- First submitted
- 19 Dec 2020
- Last updated
- 17 Mar 2023
- Results posted
- 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 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Retrolaminar Block Versus Paravertebral Block for Postoperative Analgesia in Children Undergoing Thoracoscopic Sympathectomy: a Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04688918
- Acronym / sponsor ID
- R.20.12.1115
- Conditions
- Pediatric Thoracoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 30 Dec 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.
Thoracoscopic sympathectomy is a rapid and simple technique associated with rare complications, but it is associated with severe postoperative pain that makes breathing and coughing difficult resulting in increased occurrence of pulmonary complications. Paravertebral block has frequently been performed for this procedure but its technical difficulty and safety profile may represent a limitation of its routine use. This prospective, randomized, double-blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound-guided thoracic retrolaminar block (TRLB) with the paravertebral block in children undergoing thoracoscopic sympathectomy. We hypothesize that ultrasound-guided thoracic retrolaminar block may comparable analgesic effect to paravertebral block with a lesser incidence of complications in pediatric patients undergoing thoracoscopic sympathectomy.
Detailed description
Thoracoscopic sympathectomy is a rapid and simple technique associated with rare complications, but it is associated with severe postoperative pain that makes breathing and coughing difficult resulting in increased occurrence of pulmonary complications, need for analgesic, and hospital stays. Postoperative pain control for pediatric surgeries is a major issue and affects the quality of recovery, parental satisfaction, and surgical success. Opioid usage for pediatric analgesia has many disadvantages, such as postoperative vomiting, pruritus, respiratory depression, and sedation. The introduction of anatomy-based ultrasound (US) imaging for facilitating nerve localization is a major advancement in the field of pediatric regional anesthesia. Paravertebral block has frequently been performed for this procedure but its technical difficulty and safety profile may represent a limitation of its routine use. Ultrasound-guided retrolaminar block (RLB) is a newer alternative to PV block where LA is injected between the lamina and deep paraspinal muscle, rather than between the parietal pleura and costotransverse ligament. This makes it both technically less difficult, but also at less risk of causing substantial side effects such as pneumothorax, inadvertent intrathecal injection, and neurological injury. The analgesic efficacy of RLB has been proven in adults after breast surgery, in patients with multiple rib fractures, and after acute lumbar trauma. This prospective, randomized, double-blind controlled study is designed to compare the postoperative analgesic efficacy of ultrasound-guided thoracic retrolaminar block (TRLB) with the paravertebral block in children undergoing thoracoscopic sympathectomy. We hypothesize that ultrasound-guided thoracic retrolaminar block may comparable analgesic effect to paravertebral block with a lesser incidence of complications in pediatric patients undergoing thoracoscopic sympathectomy. The study will be carried out in Mansoura university children's hospital (MUCH) after obtaining approval from Mansoura Faculty of Medicine Institutional Research Board. Informed written consent will be obtained from the patient guardians'. The planned duration of this study is 8 months. The time gap of the study will be from January 2021 to August 2020.
Eighty children of the American Society of Anesthesiologists physical status I-II of either sex with their age ranging from 8 to 18 years undergoing thoracoscopic surgeries will be recruited for the study.Exclusion criteria will include the history of clinically significant cardiac, hepatic, renal, or neurological dysfunction, coagulopathy, known allergy to amide local anesthetics, and local infection at injection sites.General anesthesia will be induced with incremental sevoflurane in 100% oxygen. After reaching an adequate depth of anesthesia, venous access was established, and then vecuronium will be given in a dose of 0.6 mg/kg and ETT will be inserted. Anesthesia was maintained under controlled ventilation with 1-1.5 MAC of isoflurane and 0.1 mg/kg vecuronium every 30 minutes as a muscle relaxant. Standard intraoperative monitors will be applied for measurement of ECG, heart rate, pulse oximetry, noninvasive blood pressure, and end-tidal carbon dioxide concentration. Baseline readings will be recorded.Computer-generated random numbering of the studied patients will be used for patient randomization before surgery. An opaque sealed envelope will be used and opened in the operative theatre by an anesthesiologist who will not be involved in the current study and who will prepare the drugs used in the study. The anesthesiologist who will be responsible for the patient and the nurse who recorded the patient data will be unaware of the patient's group. Patients will be randomly allocated to one of two equal groups (40 patients for each). Control group (n=40): the patients will receive paravertebral. block.TRLB block group (n=40): ultrasound-guided thoracic retrolaminar block (TRLB).All blocks will be performed by the same anesthetist who is experienced in US-guided pediatric nerve blocks. A high-resolution linear probe with a sterile cover will be used to perform the block. All surgical procedures will be performed by the same surgical team.All blocks will be performed by the same anesthetist who is experienced in US-guided pediatric nerve blocks... All surgical procedures will be performed by the same surgical team.The patient will be placed in a prone position with a pillow under the chest. The spinous process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high-frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vertebral lamina. An 80 mm 22-gauge needle will be inserted in an in-plane technique from cranial to the caudal direction and will be advanced till hitting the laminae of the fourth thoracic vertebrae and then we will try to inject the local anesthetic between the lamina and deep paraspinal muscle in RLB group and between the parietal pleura and costotransverse ligament in the paravertebral group. . Bupivacaine 0.25%, 0.4mL/kg will be injected. Vital signs will be recorded every 5 min after the block to ensure the adequacy of the blockade, especially after surgical incision. Surgical procedures will be allowed to start 15 min after the performance of the block. In case of an increase in either patient heart rate to more than 20% of the baseline, fentanyl at 1 ug/kg will be administered. More than 30% decrease in heart rate and systolic blood pressure, respectively, as compared with the baseline values will be treated with atropine or ephedrine as appropriate but the postoperative data of those patients will not be included in the statistical analysis.After completion of the surgery, children will be transferred to the post-anesthesia care unit (PACU) for continuous monitoring of vital signs and for pain assessment. Children will be monitored every 15 min during the first hour in the PACU and every 30 min in the daycare unit until discharge from the hospital. Postoperative analgesia will be measured using vas score 0, 1, 2, 4, 6, 12, 18, 24 hours after surgery. Patients with vas>3 will be given rescue analgesia with 0.05mg/kg morphine intravenously. The primary outcome measure is the total morphine consumption in the first postoperative 24 h. The secondary outcome measures are Postoperative pain score, Time to first rescue analgesia and its frequency, Parent's satisfaction. Block-related complications (pneumothorax, local anesthetic toxicity, or hematoma) and frequency of Nausea and vomiting. Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. The distribution of data will be first tested by the Shapiro test. Data will be presented as mean and standard deviation (SD), median, and range of numbers and percentages. For normally distributed data, an unpaired t-test will be used to compare between mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P-value ≤ of 0.05 will be considered as the level of statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| Group A (Retrolamianar block(RLB)) | Active comparator | Procedure: Retrolaminar blockUltrasound-guided RLB with injection of 0.4ml/kglocal anesthestic (bupivacaine) 0.25%will be performed under strict aseptic precautions with ultrasound guidance with patient in the prone position. |
| Paravertebral group | Active comparator | Procedure: paravertebral groupUltrasound-guided paravertebral injection of 0.4ml/kg saline 0.9% will be performed under strict aseptic precautions under ultrasound guidance with patient in the prone position. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) status: 1 or 2
- thoracoscopic sympathectomy
Key exclusion criteria (4 listed)
- history of clinically significant cardiac, hepatic, renal, or neurological dysfunction
- coagulopathy
- known allergy to amide local anesthetics
- local infection at injection sites
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 |
|---|---|---|
| Retrolaminar blockA high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The spinous process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vertebral lamina. A 50 mm 22-gauge needle will be inserted in an in-plane technique from cranial to caudal direction and will be advanced till hitting the laminae of fourth thoracic vertebrae and then we will try to inject the local anesthetic, if the resistance to injection is very high, hence we will withdraw the needle slowly and its tip will be kept in its position immediately after disappearance this high resistance. Bupivacaine 0.25%, 0.4mL/kg will be injected. | Procedure or surgery | Group A (Retrolamianar block(RLB)) |
| paravertebral groupA high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The transverse process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vcostotransverse ligament, 0.4mL/kg will be injected | Procedure or surgery | Paravertebral group |
Primary outcome
morphine consumption
Time frame: Up to 24 hours after the procedure
The total dose of morphine consumed in first 24 hours will be recorded (mg)
4 secondary outcomes
pain score
Time frame: Up to 24 hours after the procedure
number of patients who will need analgesia
Time frame: Up to 24 hours after the procedure
Block related complications
Time frame: Up to 24 hours after the procedure
time of first analgesic request (min)
Time frame: Up to 24 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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.
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrolaminar block and paravertebral group in people with Pediatric Thoracoscopy, run by Mansoura 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 2 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: Up to 24 hours after the procedure). 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 17 Mar 2023.