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Clinical Trials/NCT04442750
NCT04442750
Unknown
Not Applicable

Comparison of the Analgesic Efficacy of Three Different Concentrations of Bupivacaine in Ultrasound Guided Erector Spinae Plane Block in Hip Surgeries: Randomized Control Trial

Cairo University1 site in 1 country100 target enrollmentJune 22, 2020

Overview

Phase
Not Applicable
Intervention
Erector spinae plane block Technique
Conditions
Postoperative Pain
Sponsor
Cairo University
Enrollment
100
Locations
1
Primary Endpoint
The total 24 hours amount of morphine consumption
Last Updated
5 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
June 22, 2020
End Date
November 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bassant M. Abdelhamid

associate professor

Cairo University

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.

Arms & Interventions

A (0.5%) group

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

Intervention: Erector spinae plane block Technique

A (0.5%) group

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

Intervention: General anesthesia

A (0.5%) group

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

Intervention: Bupivacaine 0.5%

B (0.375%) group

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

Intervention: Erector spinae plane block Technique

B (0.375%) group

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

Intervention: General anesthesia

B (0.375%) group

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

Intervention: Bupivacaine 0.375%

C (0.25%) group

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

Intervention: Erector spinae plane block Technique

C (0.25%) group

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

Intervention: General anesthesia

C (0.25%) group

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

Intervention: Bupivacaine 0.25%

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Sites (1)

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