Different Concentrations of Bupivacaine in Erector Spinae Plane Block in Hip Surgeries

NCT04442750 | Unknown

• 1 other identifier: N-29-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The total 24 hours amount of morphine consumption

  The total amount of morphine consumption in the first 24 hours postoperatively

  24 hours postoperative

Secondary Outcomes (4)

• Total amount of intraoperative fentanyl

  2 hours intraoperatively

• Numeric Pain Rating Scale

  24 hours postoperative

• Time for first rescue analgesia

  24 hours

• Block related complications

  24 hours postoperative

Study Arms (3)

A (0.5%) group

EXPERIMENTAL

patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia

Procedure: Erector spinae plane block Technique; Procedure: General anesthesia; Drug: Bupivacaine 0.5%

B (0.375%) group

EXPERIMENTAL

patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia

Procedure: Erector spinae plane block Technique; Procedure: General anesthesia; Drug: Bupivacaine 0.375%

C (0.25%) group

EXPERIMENTAL

patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia

Procedure: Erector spinae plane block Technique; Procedure: General anesthesia; Drug: Bupivacaine 0.25%

Interventions

Erector spinae plane block Technique PROCEDURE

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.

A (0.5%) group; B (0.375%) group; C (0.25%) group

General anesthesia PROCEDURE

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.

A (0.5%) group; B (0.375%) group; C (0.25%) group

Bupivacaine 0.5% DRUG

The patient will receive 30ml bupivacain 0.5% in erector spinae block

A (0.5%) group

Bupivacaine 0.375% DRUG

The patient will receive 30ml bupivacain 0.375% in erector spinae block

B (0.375%) group

Bupivacaine 0.25% DRUG

The patient will receive 30ml bupivacain 0.25% in erector spinae block

C (0.25%) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 29522966 BACKGROUND

• 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.

  PMID: 30662115 BACKGROUND

• 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.

  PMID: 29576256 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Bassant abdelhamid, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bassant abdelhamid, M.D.

CONTACT

01224254012; bassantmohamed197@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: June 22, 2020
• Primary Completion: October 20, 2020
• Study Completion: November 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)