Clinical trial NCT04442750: Different Concentrations of Bupivacaine in Erector Spinae Plane Block in Hip Surgeries
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of hip replacement surgery is increasing nowadays. Patients are usually older age and suffer from comorbidities may be an anesthetic and analgesic challenge. Erector spinae plane block (ESPB) is a newly described technique that is has been demonstrated in previous studies for chronic and acute pain treatment. The exact volume and concentration of local anesthetic (LA) to be used in ESPB is not well established.

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

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: The total 24 hours amount of morphine consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Total amount of intraoperative fentanyl
timeFrame: 2 hours intraoperatively
measure: Numeric Pain Rating Scale
timeFrame: 24 hours postoperative
measure: Time for first rescue analgesia
timeFrame: 24 hours
measure: Block related complications
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Bassant abdelhamid, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.