ESP Block vs FIB in Patients Undergoing Hip Arthroplasty
Primary Purpose
Hip Arthropathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector spinae plain block
Fascia Iliaca block
Sponsored by
About this trial
This is an interventional other trial for Hip Arthropathy focused on measuring Erector spinae block, Fascia iliaca block
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years
- ASA grade I to II
- Patients scheduled for hip replacement surgeries under subarachnoid block (SAB) e.g. hip hemi-arthroplasty, total hip arthroplasty
Exclusion Criteria:
- Patient refusal
- Age below 18 or above 65 years.
- ASA grade III to IV
- Patients with known allergies to any of the drugs used.
- Contraindication to SAB eg. Coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies.
- Patients receiving opioids for chronic analgesic therapy
- Inability to comprehend visual analogue scale (VAS)
- Infection at site of erector spinae or fascia iliaca block.
- Body mass index >35 kg/m2
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ESPB Group
FIB Group
Arm Description
This group will receive ultrasound-guided erector spinae plane block and subarachnoid block.
This group will receive supra-inguinal fascia iliaca block and subarachnoid block .
Outcomes
Primary Outcome Measures
Total morphine requirements
Amount of morphine required postoperatively
Secondary Outcome Measures
Visual analogue pain score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time to first postoperative analgesic request
If the visual analogue scale (VAS) was 4 or more, a morphine increment (2 mg) will be added to maintain a resting VAS at <3 and the total 24-hours morphine consumption will be recorded.
Quadriceps muscle power strength
For motor block assessment, the patient knee will be fully flexed and the patient will be asked to extend it. The motor block will be classified as follows: grade 0; normal muscle power, grade 1; motor weakness, grade 2; complete motor paralysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05015517
Brief Title
ESP Block vs FIB in Patients Undergoing Hip Arthroplasty
Official Title
Comparison of Ultrasound Guided Erector Spinae Block and Supra-inguinal Fascia Iliaca Block for Postoperative Analgesia in Patients Undergoing Hip Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
October 2022 (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
5. Study Description
Brief Summary
The aim of this study is to compare between the analgesic efficacy of ESP block and FIB in patients undergoing hip arthroplasty.
Detailed Description
Hip arthroplasty surgery is usually associated with severe postoperative pain. Several modalities are usually used for postoperative analgesia in these patients, those include; intravenous analgesia, neuraxial analgesia and peripheral nerve blocks.
Peripheral nerve blocks have several advantages such as; potent analgesia, lower motor impairment and minimal systemic complications.
Lumbar plexus block and supra-inguinal fascia iliaca block (FIB) are the most commonly performed peripheral nerve blocks for hip surgeries.
Fascia iliaca block is one of the most common techniques for pain control after hip surgeries; it can be regarded as an anterior approach of the lumbar plexus. It provides analgesia through spread of local anaesthetic to the femoral and lateral cutaneous femoral nerves.
Ultrasound guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described in 2016 for acute and chronic thoracic pain management. It is a paraspinal fascial plane block that provides analgesia through injecting local anesthetic drugs to block the ventral and dorsal rami of spinal nerves in the paravertebral area.
To the best of the investigators knowledge, the use of ESP block in hip surgery was only investigated in one study and few case reports. Therefore, further randomized controlled studies are needed to prove this hypothesis.
This study aims to investigate the efficacy of ESP block in hip replacement compared to the supra-inguinal FIB.
The investigators hypothesize that erector spinae block may provide better postoperative analgesia than fascia iliaca block, since erector spinae block provides analgesic cover for the entire lumbar plexus rather than just peripheral nerves provided by fasicia iliaca.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
Keywords
Erector spinae block, Fascia iliaca block
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
computer-generated sequence. Concealment will be achieved using opaque envelopes. All data will be collected blindly and the authors will perform the blocks without interference in data collection.
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESPB Group
Arm Type
Active Comparator
Arm Description
This group will receive ultrasound-guided erector spinae plane block and subarachnoid block.
Arm Title
FIB Group
Arm Type
Active Comparator
Arm Description
This group will receive supra-inguinal fascia iliaca block and subarachnoid block .
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plain block
Intervention Description
Patients will be placed in the lateral position.Ultrasonography will be performed by an experienced anesthetist.The 4th lumbar vertebral level will be determined using the conventional method (imaginary line between two iliac crests). The low frequency convex probe (2-5MHz) will then be placed at the mid-vertebral line in the sagittal plane. It will be shifted from the midline, 3.5-4 cm lateral to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-plane technique a 22G/80-mm block needle will be advanced until it reaches the transverse process. After negative aspiration, 0.5-1 ml of the prepared local anaesthetic solution (20 ml bupivacaine 0.5%, 10 ml lidocaine 2%) and 10 ml normal saline will be administered for hydrodissection to confirm correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when injecting local anesthesia
Intervention Type
Procedure
Intervention Name(s)
Fascia Iliaca block
Intervention Description
Patients will be placed in supine position. Ultrasonography will be performed by an experienced anesthetist using ultrasound device equipped with a low frequency (2-5 MHz) convex probe and an echogenic 21 G/ 10 cm needle will be used.
The probe will be placed in the inguinal crease. Scan will be started laterally from the femoral artery and nerve in the inguinal crease to identify the Sartorius muscle. The muscle will then be traced until its origin at the anterior superior iliac spine is identified and the shadow of the bony of iliac crest & iliacus muscle will be seen. Injection will be performed at the plane deep to the fascia iliaca and above the lateral part of the iliacus muscle. After negative aspiration, the prepared local anaesthetic solution (15 ml bupivacaine 0.5%, 15 ml normal saline) will be injected incrementally, aspirating every 5 ml.
Primary Outcome Measure Information:
Title
Total morphine requirements
Description
Amount of morphine required postoperatively
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Visual analogue pain score
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
at rest at 2, 4, 6, 12, 18, and 24 hours postoperatively
Title
Time to first postoperative analgesic request
Description
If the visual analogue scale (VAS) was 4 or more, a morphine increment (2 mg) will be added to maintain a resting VAS at <3 and the total 24-hours morphine consumption will be recorded.
Time Frame
24 hours postoperatively
Title
Quadriceps muscle power strength
Description
For motor block assessment, the patient knee will be fully flexed and the patient will be asked to extend it. The motor block will be classified as follows: grade 0; normal muscle power, grade 1; motor weakness, grade 2; complete motor paralysis
Time Frame
at 6, 12 and 24 hours postoperatively
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:
Age between 18 and 65 years
ASA grade I to II
Patients scheduled for hip replacement surgeries under subarachnoid block (SAB) e.g. hip hemi-arthroplasty, total hip arthroplasty
Exclusion Criteria:
Patient refusal
Age below 18 or above 65 years.
ASA grade III to IV
Patients with known allergies to any of the drugs used.
Contraindication to SAB eg. Coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies.
Patients receiving opioids for chronic analgesic therapy
Inability to comprehend visual analogue scale (VAS)
Infection at site of erector spinae or fascia iliaca block.
Body mass index >35 kg/m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed MA Moawad, Ass.lecturer
Phone
01098189096
Ext
+2
Email
ahmedmohammed621991@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sheren Refaat, A.Professor
Phone
01005607829
Ext
+2
Email
Sherin.refaat@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf RA Aswa, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://journals.lww.com/anesthesia-analgesia/fulltext/2002/06000/continuous_psoas_compartment_block_for.45.aspx
Description
Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation
URL
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=+Nye+ZB%2C+Horn+JL%2C+Crittenden+W%2C+Abrahams+MS%2C+Aziz+MF.+Ambulatory+continuous+posterior+lumbar+plexus+blocks+following+hip+arthroscopy%3A+a+review+of+213+cases.%C2%A0J+Clin+Anesth.%C2%A02013+Jun%3B25%284%29%3A268-274.++Bullock+WM&btnG=#d=gs_qabs&u=%23p%3DCrp2CiuaHgMJ
Description
Abrahams MS, Aziz MF. Ambulatory continuous posterior lumbar plexus blocks following hip arthroscopy: a review of 213 cases
URL
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Bullock+WM%2C%C2%A0Yalamuri+SM%2C%C2%A0Gregory+SH%2C%C2%A0Auyong+DB%2C%C2%A0Grant+SA%2C+Ultrasound-Guided+Suprainguinal+Fascia+Iliaca+Technique+Provides+Benefit+as+an+Analgesic+Adjunct+for+Patients+Undergoing+Total%C2%A0Hip%C2%A0Arthroplasty%2C+J+Ultrasound+Med.%2C+2017+Feb%3B36%282%29%3A433-438.&btnG=#d=gs_qabs&u=%23p%3DNHm8V774Mx0J
Description
Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty
URL
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Desmet%C2%A0M%2C%C2%A0Vermeylen%C2%A0K%2C%C2%A0Van+Herreweghe%C2%A0I%2C+et+al.A+Longitudinal+Supra-Inguinal+Fascia+Iliaca+Compartment+Block+Reduces+Morphine+Consumption+After+Total+Hip+Arthroplasty.Regional+Anesthesia+%26Pain+Medicine%C2%A02017%3B42%3A327-333.&btnG=#d=gs_qabs&u=%23p%3D4cdBlf-qnskJ
Description
Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty
URL
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=++Forero+M%2C+Adhikary+SD%2C+Lopez+H%2C+et+al.+The+erector+spinae+plane+block%3A+a+novel+analgesic+technique+in+thoracic+neuropathic+pain.+Reg+Anesth+Pain+Med.+2016%3B41%285%29%3A621%E2%80%93627.&btnG=#d=gs_qabs&u=%23p%3DFSUO-gw42YEJ
Description
The erector spinae plane block: a novel analgesic technique in thoracic neuropathic pain.
URL
https://search.proquest.com/openview/70d234ac1634867694810005281fe12a/1?pq-origsite=gscholar&cbl=226517
Description
Erector spinae plane block an effective block for postoperative analgesia in modified radical mastectomy.
Learn more about this trial
ESP Block vs FIB in Patients Undergoing Hip Arthroplasty
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