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Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
quadratus lumborum block; (Anterior QLB or QLB III)
suprainguinal fascia iliaca block
Subarachnoid block
Sponsored by
Bassant M. Abdelhamid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

Exclusion Criteria:

  • Coagulopathy, infection at the injection site,.
  • Allergy to local anesthetics.
  • Severe cardiopulmonary disease (≥ASA IV),.
  • Diabetic or other neuropathies.
  • Patients receiving opioids for chronic analgesic therapy.
  • Contraindication to spinal anesthesia.
  • Inability to comprehend visual analogue scale (VAS).

Sites / Locations

  • Anesthesia DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

QLB Group

FIB Group

Arm Description

this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)

this group will receive suprainguinal fascia iliaca block

Outcomes

Primary Outcome Measures

Duration of analgesia
If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.

Secondary Outcome Measures

Static visual analogue pain scale
Visual analogue pain scale (VAS) at rest. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Dynamic visual analogue pain scale
Visual analogue pain scale (VAS) on movement. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Onset of sensory block of quadratus lumborum block and fascia iliaca block
the time interval between the injection of the study medication till complete loss of sensation
Time to first postoperative analgesic request
morphine increment will be added per time to maintain a resting VAS at <3 with maximum
Total morphine requirements
If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
Assessment of the quadriceps muscle power.
the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
Time needed to perform the block
the total time of the procedure (quadratus lumborum block or fascia iliaca block) started from patient positioning till completion of local anesthesia injection.
incidence of pain during positioning for spinal block
to assess the ability of either two types of the the blocks to relieve pain during positioning for spinal anesthesia

Full Information

First Posted
June 26, 2019
Last Updated
July 5, 2019
Sponsor
Bassant M. Abdelhamid
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1. Study Identification

Unique Protocol Identification Number
NCT04005326
Brief Title
Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty
Official Title
Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
October 5, 2019 (Anticipated)
Study Completion Date
October 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bassant M. Abdelhamid

4. Oversight

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

5. Study Description

Brief Summary
Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection. This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.
Detailed Description
A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty. On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry. Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups: QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative. After finishing the block & assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room. Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours. If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLB Group
Arm Type
Experimental
Arm Description
this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)
Arm Title
FIB Group
Arm Type
Experimental
Arm Description
this group will receive suprainguinal fascia iliaca block
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum block; (Anterior QLB or QLB III)
Intervention Description
The patient will be in the lateral position. A low frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.
Intervention Type
Procedure
Intervention Name(s)
suprainguinal fascia iliaca block
Intervention Description
In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
Intervention Type
Procedure
Intervention Name(s)
Subarachnoid block
Other Intervention Name(s)
spinal anesthesia
Intervention Description
Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load. Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study.
Primary Outcome Measure Information:
Title
Duration of analgesia
Description
If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Static visual analogue pain scale
Description
Visual analogue pain scale (VAS) at rest. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Time Frame
24 hours postoperative
Title
Dynamic visual analogue pain scale
Description
Visual analogue pain scale (VAS) on movement. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Time Frame
24 hours postoperative
Title
Onset of sensory block of quadratus lumborum block and fascia iliaca block
Description
the time interval between the injection of the study medication till complete loss of sensation
Time Frame
30 minutes
Title
Time to first postoperative analgesic request
Description
morphine increment will be added per time to maintain a resting VAS at <3 with maximum
Time Frame
24 hours postoperative
Title
Total morphine requirements
Description
If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
Time Frame
24 hours postoperative
Title
Assessment of the quadriceps muscle power.
Description
the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
Time Frame
24 hours
Title
Time needed to perform the block
Description
the total time of the procedure (quadratus lumborum block or fascia iliaca block) started from patient positioning till completion of local anesthesia injection.
Time Frame
30 minutes
Title
incidence of pain during positioning for spinal block
Description
to assess the ability of either two types of the the blocks to relieve pain during positioning for spinal anesthesia
Time Frame
30 minutes

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: Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty. Exclusion Criteria: Coagulopathy, infection at the injection site,. Allergy to local anesthetics. Severe cardiopulmonary disease (≥ASA IV),. Diabetic or other neuropathies. Patients receiving opioids for chronic analgesic therapy. Contraindication to spinal anesthesia. Inability to comprehend visual analogue scale (VAS).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M. Hasanin, M.D.
Phone
+201095076954
Email
ahmedmohamedhasanin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud swilem
Phone
+201008855731
Email
mr.sewilam@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M. Hasanin, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesia Department
City
Cairo
ZIP/Postal Code
1772
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid, M.D.
Phone
01224254012
Email
bassantmohamed197@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmed Hassanin, M.D.
First Name & Middle Initial & Last Name & Degree
Mahmoud Swilem

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27943417
Citation
Bullock WM, Yalamuri SM, Gregory SH, Auyong DB, Grant SA. Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty. J Ultrasound Med. 2017 Feb;36(2):433-438. doi: 10.7863/ultra.16.03012. Epub 2016 Dec 10.
Results Reference
background
PubMed Identifier
24249997
Citation
Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
Results Reference
background
PubMed Identifier
28154824
Citation
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
Results Reference
background
PubMed Identifier
27684871
Citation
Bang S, Chung J, Jeong J, Bak H, Kim D. Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine (Baltimore). 2016 Sep;95(39):e5018. doi: 10.1097/MD.0000000000005018.
Results Reference
background
PubMed Identifier
33907462
Citation
Nassar H, Hasanin A, Sewilam M, Ahmed H, Abo-Elsoud M, Taalab O, Rady A, Zoheir HA. Transmuscular Quadratus Lumborum Block versus Suprainguinal Fascia Iliaca Block for Hip Arthroplasty: A Randomized, Controlled Pilot Study. Local Reg Anesth. 2021 Apr 20;14:67-74. doi: 10.2147/LRA.S308964. eCollection 2021.
Results Reference
derived

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Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty

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