Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
NCT ID: NCT04003909
Last Updated: 2019-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-07-05
2019-11-06
Brief Summary
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Detailed Description
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All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15 per group:
Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided ESP block before spinal anesthesia.
Group C, Control group (n=15): prior to surgical incision, patients will have spinal Anesthesia without ESP block .
Patients will be randomly allocated by a computer-generated table into one of the study groups, the randomization sequence will be concealed in sealed opaque envelopes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ESP group
patients will have ultrasound guided ESP block before spinal anesthesia.
ultrasound-guided Erector spinae plane block
The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
subarachonoid block
Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
Control group
patients will have spinal Anesthesia without ESP block
subarachonoid block
Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
Interventions
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ultrasound-guided Erector spinae plane block
The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
subarachonoid block
Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* ASA I-II.
* Undergo hip replacement surgery.
* Body mass index (BMI) from 18 to 35 kg/m2.
Exclusion Criteria
* Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, etc. )
* BMI \> 35.
* Known allergy to local anesthetics.
* ASA III-IV.
* Patients with difficulty in evaluating their level of pain.
18 Years
65 Years
ALL
No
Sponsors
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Bassant M. Abdelhamid
OTHER
Responsible Party
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Bassant M. Abdelhamid
associate professor
Principal Investigators
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Ashraf Rady, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Amr abdelnasser
Role: STUDY_DIRECTOR
Cairo University
Locations
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Anesthesia Department
Cairo, , Egypt
Countries
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References
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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.
Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.
Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.
Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
Other Identifiers
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N-147-2018
Identifier Type: -
Identifier Source: org_study_id
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