- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442750
Different Concentrations of Bupivacaine in Erector Spinae Plane Block in Hip Surgeries
Comparison of the Analgesic Efficacy of Three Different Concentrations of Bupivacaine in Ultrasound Guided Erector Spinae Plane Block in Hip Surgeries: Randomized Control Trial
Study Overview
Status
Conditions
Detailed Description
Aim of the work is to compare the analgesic effects of three different concentrations of the same volume of local anesthetics; 30 ml of 0.50% vs 0.375% vs 0.25% bupivacaine in patients undergoing hip surgeries.
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
- Group F: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.50% bupivacaine.
- Group M: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.375% bupivacaine.
- Group H: 44 patients will receive single shot of erector spinae block at the level of L4with 30ml 0.25% bupivacaine .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bassant abdelhamid, M.D.
- Phone Number: 01224254012
- Email: bassantmohamed197@yahoo.com
Study Locations
-
-
-
Cairo, Egypt, 11562
- Recruiting
- Cairo University
-
Contact:
- Bassant M. Abdelhamid, M. D.
- Phone Number: 002 01224254012
- Email: Bassantmohamed197@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Both genders (Males and females).
- 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:
- Patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A (0.5%) group
patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
|
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.
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.
The patient will receive 30ml bupivacain 0.5% in erector spinae block
|
Experimental: B (0.375%) group
patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
|
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.
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.
The patient will receive 30ml bupivacain 0.375% in erector spinae block
|
Experimental: C (0.25%) group
patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
|
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.
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.
The patient will receive 30ml bupivacain 0.25% in erector spinae block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total 24 hours amount of morphine consumption
Time Frame: 24 hours postoperative
|
The total amount of morphine consumption in the first 24 hours postoperatively
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total amount of intraoperative fentanyl
Time Frame: 2 hours intraoperatively
|
2 hours intraoperatively
|
|
Numeric Pain Rating Scale
Time Frame: 24 hours postoperative
|
Numeric Pain Rating Scale, both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24 hours postoperatively.
The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the patient rates the pain from 0 (no pain) to 10 (worst pain).
|
24 hours postoperative
|
Time for first rescue analgesia
Time Frame: 24 hours
|
24 hours
|
|
Block related complications
Time Frame: 24 hours postoperative
|
• Block related complications such as local anesthetic toxicity, hematoma formation and lower limb weakness.
|
24 hours postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-29-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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