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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector spinae plane block Technique
General anesthesia
Bupivacaine 0.5%
Bupivacaine 0.375%
Bupivacaine 0.25%
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A (0.5%) group

B (0.375%) group

C (0.25%) group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total amount of intraoperative fentanyl
Numeric Pain Rating Scale
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
Block related complications
• Block related complications such as local anesthetic toxicity, hematoma formation and lower limb weakness.

Full Information

First Posted
June 17, 2020
Last Updated
July 13, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04442750
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Group F: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.50% bupivacaine. Group M: 44 patients will receive single shot erector spinae block at the level of L4 with 30 ml 0.375% bupivacaine. Group H: 44 patients will receive single shot of erector spinae block at the level of L4with 30ml 0.25% bupivacaine .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (0.5%) group
Arm Type
Experimental
Arm Description
patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
Arm Title
B (0.375%) group
Arm Type
Experimental
Arm Description
patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
Arm Title
C (0.25%) group
Arm Type
Experimental
Arm Description
patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block Technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5%
Intervention Description
The patient will receive 30ml bupivacain 0.5% in erector spinae block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.375%
Intervention Description
The patient will receive 30ml bupivacain 0.375% in erector spinae block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Intervention Description
The patient will receive 30ml bupivacain 0.25% in erector spinae block
Primary Outcome Measure Information:
Title
The total 24 hours amount of morphine consumption
Description
The total amount of morphine consumption in the first 24 hours postoperatively
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Total amount of intraoperative fentanyl
Time Frame
2 hours intraoperatively
Title
Numeric Pain Rating Scale
Description
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 Frame
24 hours postoperative
Title
Time for first rescue analgesia
Time Frame
24 hours
Title
Block related complications
Description
• Block related complications such as local anesthetic toxicity, hematoma formation and lower limb weakness.
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant abdelhamid, M.D.
Phone
01224254012
Email
bassantmohamed197@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant M. Abdelhamid, M. D.
Phone
01224254012
Ext
002
Email
Bassantmohamed197@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29522966
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.
Results Reference
background
PubMed Identifier
30662115
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.
Results Reference
background
PubMed Identifier
29576256
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.
Results Reference
background

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

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