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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Erector spinae plane block Technique; Procedure: General anesthesia; Drug: Bupivacaine 0.5%; Drug: Bupivacaine 0.25%; Drug: Bupivacaine 0.375%

• Registration Number: NCT04442750
• Lead Sponsor: Cairo University

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 .

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-19
• Study Start: 2020-06-22
• Study First Posted: 2020-06-23
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14
• Primary Completion: 2020-10-20
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (0.5%) group	Bupivacaine 0.5%	patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
A (0.5%) group	Erector spinae plane block Technique	patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
A (0.5%) group	General anesthesia	patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
C (0.25%) group	Bupivacaine 0.25%	patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
B (0.375%) group	General anesthesia	patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
C (0.25%) group	Erector spinae plane block Technique	patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
C (0.25%) group	General anesthesia	patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
B (0.375%) group	Erector spinae plane block Technique	patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
B (0.375%) group	Bupivacaine 0.375%	patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia

Primary Outcome Measures

Name	Time	Method
The total 24 hours amount of morphine consumption	24 hours postoperative	The total amount of morphine consumption in the first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Total amount of intraoperative fentanyl	2 hours intraoperatively
Numeric Pain Rating Scale	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).
Time for first rescue analgesia	24 hours
Block related complications	24 hours postoperative	• Block related complications such as local anesthetic toxicity, hematoma formation and lower limb weakness.

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt