NCT04005326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

June 26, 2019

Last Update Submit

July 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours postoperative

Secondary Outcomes (8)

  • Static visual analogue pain scale

    24 hours postoperative

  • Dynamic visual analogue pain scale

    24 hours postoperative

  • Onset of sensory block of quadratus lumborum block and fascia iliaca block

    30 minutes

  • Time to first postoperative analgesic request

    24 hours postoperative

  • Total morphine requirements

    24 hours postoperative

  • +3 more secondary outcomes

Study Arms (2)

QLB Group

EXPERIMENTAL

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

Procedure: quadratus lumborum block; (Anterior QLB or QLB III)Procedure: Subarachnoid block

FIB Group

EXPERIMENTAL

this group will receive suprainguinal fascia iliaca block

Procedure: suprainguinal fascia iliaca blockProcedure: Subarachnoid block

Interventions

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.

QLB Group

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.

FIB Group

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.

Also known as: spinal anesthesia
FIB GroupQLB Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department

Cairo, 1772, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27943417BACKGROUND
  • 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.

    PMID: 24249997BACKGROUND
  • 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.

    PMID: 28154824BACKGROUND
  • 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.

    PMID: 27684871BACKGROUND
  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Ahmed M. Hasanin, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M. Hasanin, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 2, 2019

Study Start

July 5, 2019

Primary Completion

October 5, 2019

Study Completion

October 15, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations