Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Study Overview
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Brief Summary
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ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and low risk for serious complications as injection is into tissue plane that is distant from pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be performed at the level of L4. In a recent case report, ultrasound guided ESP block was successfully performed at L4 transverse process level for postoperative analgesia after total hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement surgeries needed more investigation.

Detailed Description
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This study will be performed in Cairo university hospital. Thirty adult patients of both sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the study. 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.

Official Title
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Effectiveness of Ultrasound-guided Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: ultrasound-guided Erector spinae plane block
* Procedure: subarachonoid block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged from 40 to 65 years old Both sexes. ASA I-II. Undergo hip replacement surgery. Body mass index (BMI) from 18 to 35 kg/m2. Exclusion Criteria: Patient refusal. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP group<br>patients will have ultrasound guided ESP block before spinal anesthesia. | Procedure: ultrasound-guided Erector spinae plane block<br>* 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.<br>Procedure: subarachonoid block<br>* 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.<br>|
| Experimental: Control group<br>patients will have spinal Anesthesia without ESP block | Procedure: subarachonoid block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | Total morphine consumption in rescue boluses during 1st 24 hrs postoperatively. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | Visual analogue scale at the following intervals:30 minutes,2,4, 6, 12, and 24 hours postoperative. | 30 minutes,2,4, 6, 12, and 24 hours postoperative. | 
| Duration of analgesia | defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic in the form of iv morphine | 24 hours postoperative | 
| Incidence of complications | Nerve injury, Hematoma formation, LA toxicity, Intravascular injection. | 24 hours |