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

Cairo University (CU)

Status: Unknown

Conditions: Postoperative Pain

Treatments: Procedure: Erector spinae plane block Technique; Procedure: General anesthesia; Drug: Bupivacaine 0.5%; Drug: Bupivacaine 0.25%; Drug: Bupivacaine 0.375%

Study type: Interventional

Funder types: Other

Identifiers

NCT04442750

N-29-2020

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups

A (0.5%) group

Experimental group

Description:

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

Treatment:

Procedure: General anesthesia

Drug: Bupivacaine 0.5%

Procedure: Erector spinae plane block Technique

B (0.375%) group

Experimental group

Description:

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

Treatment:

Procedure: General anesthesia

Procedure: Erector spinae plane block Technique

Drug: Bupivacaine 0.375%

C (0.25%) group

Experimental group

Description:

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

Treatment:

Procedure: General anesthesia

Drug: Bupivacaine 0.25%

Procedure: Erector spinae plane block Technique