We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005326
Recruitment Status : Unknown
Verified July 2019 by Bassant M. Abdelhamid, Cairo University.
Recruitment status was:  Recruiting
First Posted : July 2, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bassant M. Abdelhamid, Cairo University

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.


Condition or disease Intervention/treatment Phase
Post Operative Pain Procedure: quadratus lumborum block; (Anterior QLB or QLB III) Procedure: suprainguinal fascia iliaca block Procedure: Subarachnoid block Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : October 15, 2019

Arm Intervention/treatment
Experimental: QLB Group
this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)
Procedure: quadratus lumborum block; (Anterior QLB or QLB III)
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.

Procedure: Subarachnoid block

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.

Other Name: spinal anesthesia

Experimental: FIB Group
this group will receive suprainguinal fascia iliaca block
Procedure: suprainguinal fascia iliaca block
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.

Procedure: Subarachnoid block

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.

Other Name: spinal anesthesia




Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 24 hours postoperative ]
    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 :
  1. Static visual analogue pain scale [ Time Frame: 24 hours postoperative ]
    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]).

  2. Dynamic visual analogue pain scale [ Time Frame: 24 hours postoperative ]
    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]).

  3. Onset of sensory block of quadratus lumborum block and fascia iliaca block [ Time Frame: 30 minutes ]
    the time interval between the injection of the study medication till complete loss of sensation

  4. Time to first postoperative analgesic request [ Time Frame: 24 hours postoperative ]
    morphine increment will be added per time to maintain a resting VAS at <3 with maximum

  5. Total morphine requirements [ Time Frame: 24 hours postoperative ]
    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. Assessment of the quadriceps muscle power. [ Time Frame: 24 hours ]
    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

  7. Time needed to perform the block [ Time Frame: 30 minutes ]
    the total time of the procedure (quadratus lumborum block or fascia iliaca block) started from patient positioning till completion of local anesthesia injection.

  8. incidence of pain during positioning for spinal block [ Time Frame: 30 minutes ]
    to assess the ability of either two types of the the blocks to relieve pain during positioning for spinal anesthesia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005326


Contacts
Layout table for location contacts
Contact: Ahmed M. Hasanin, M.D. +201095076954 ahmedmohamedhasanin@gmail.com
Contact: Mahmoud swilem +201008855731 mr.sewilam@gmail.com

Locations
Layout table for location information
Egypt
Anesthesia Department Recruiting
Cairo, Egypt, 1772
Contact: Bassant abdelhamid, M.D.    01224254012    bassantmohamed197@yahoo.com   
Principal Investigator: Ahmed Hassanin, M.D.         
Sub-Investigator: Mahmoud Swilem         
Sponsors and Collaborators
Bassant M. Abdelhamid
Investigators
Layout table for investigator information
Principal Investigator: Ahmed M. Hasanin, M.D. Cairo University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bassant M. Abdelhamid, associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT04005326    
Other Study ID Numbers: N-144-2018
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations