Different Concentrations of Bupivacaine in Erector Spinae Plane Block in Hip Surgeries
NCT ID: NCT04442750
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-06-22
2020-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Analgesic Effect of Ultrasound-guided Sacral Erector Spinae, Pericapsular Nerve Block and Lumber Plexus Block for Pain Relief for Hip Surgery: Randomized Controlled Study
NCT06842342
Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients
NCT05788458
Pericapsular Nerve Group and Lumbar Erector Spinae Plane Blocks for Geriatrics Undergoing Total Hip Arthroplasty
NCT06904703
Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries
NCT04628689
Volume Versus Concentration: Clinical Effectiveness of Single Shot Quadrates Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.
NCT04259645
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Prospective randomized double blinded study that will be conducted in at Kasr El-Ainy hospital orthopedic surgical theater.
patients, undergoing hip surgeries will be randomly allocated into three equal groups, each (n=44), using computerized generated random tables
1. Group F: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.50% bupivacaine.
2. Group M: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.375% bupivacaine.
3. Group H: 44 patients will receive single shot of erector spinae block at the level of L4with 30ml 0.25% bupivacaine .
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A (0.5%) group
patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
Erector spinae plane block Technique
The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.
General anesthesia
Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\\kg will be provided every 30 minutes.
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes.
Bupivacaine 0.5%
The patient will receive 30ml bupivacain 0.5% in erector spinae block
B (0.375%) group
patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
Erector spinae plane block Technique
The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.
General anesthesia
Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\\kg will be provided every 30 minutes.
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes.
Bupivacaine 0.375%
The patient will receive 30ml bupivacain 0.375% in erector spinae block
C (0.25%) group
patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
Erector spinae plane block Technique
The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.
General anesthesia
Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\\kg will be provided every 30 minutes.
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes.
Bupivacaine 0.25%
The patient will receive 30ml bupivacain 0.25% in erector spinae block
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erector spinae plane block Technique
The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.
General anesthesia
Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\\kg will be provided every 30 minutes.
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes.
Bupivacaine 0.5%
The patient will receive 30ml bupivacain 0.5% in erector spinae block
Bupivacaine 0.375%
The patient will receive 30ml bupivacain 0.375% in erector spinae block
Bupivacaine 0.25%
The patient will receive 30ml bupivacain 0.25% in erector spinae block
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Type of surgery; unilateral elective hip surgeries
* Physical status ASA I, II.
* Age ≥ 18 and ≤ 65 Years.
* Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
Exclusion Criteria
* History of psychological disorders and/or chronic pain.
* Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
* Infection of the skin at the site of needle puncture area.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Advanced liver or kidney disease.
* Pregnancy.
* Patient with surgery duration more than two hours.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bassant M. Abdelhamid
associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bassant abdelhamid, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo university
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
Kashani HH, Grocott HP. Clarity needed as to the optimal dose and volume of local anesthetic for erector spinae plane blockade for posterior rib fractures. Am J Emerg Med. 2018 Jun;36(6):1102-1103. doi: 10.1016/j.ajem.2018.03.032. Epub 2018 Mar 15. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-29-2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.