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Quadratus Lumborum Block and Rectus Sheath BlockNCT06403020

Ultrasound-guided Quadratus Lumborum Block Versus Rectus Sheath Block

A study testing Block in people with Quadratus Lumborum Block and Rectus Sheath Block, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study we will compare the effectiveness of quadratus lumborum block and rectus sheath block in postoperative pain management after paraumbilical hernia repair Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
3 May 2024to 15 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients 18-60 years old,
  • American Society of Anesthesiology (ASA) I, Ⅱ,
  • both sexes who will have PUH surgical repair under general anesthesia.

Who cannot join

  • Known allergy to any of the drugs that will be used in the study.
  • Coagulation disorders.
  • Infection at the site of injection.
  • Liver or kidney disease

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University Hospital

    Al Fayyum, 63511

Other trials in Egypt

About this study

Official title: Ultrasound-guided Quadratus Lumborum Block Versus Rectus Sheath Block in Paraumbilical Hernia in Adults: A Prospective Randomized Study

In this study we will compare the effectiveness of quadratus lumborum block and rectus sheath block in postoperative pain management after paraumbilical hernia repair

Read the detailed description

patients will be allocated randomly into two groups by a computer generated sequence using closed envelope method. Group Q (n=23) will have qadratus lumboroum (QL) block.

Group R (n=23) will have rectus sheath (RS) block. Surgery will be performed by the same surgeon and the block also will be done by same anesthesiologist who will not be involved in postoperative assessment.

All patients will have a preoperative history taking, clinical examination and routine preoperative laboratory investigations will be done. Patients also will be learned how to deal with the VAS score before surgery. The visual analog scale (VAS) is a pain score at which a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, used to track pain for a patient or to compare pain between patients.(12,13) At operating room (OR), patients will be monitored by noninvasive blood blood pressure(NABP), peripheral oxygen saturation (spo2) and and electrocardiogram ( ECG). A peripheral intravenous cannula will be inserted. Patients will be premedicated by midazolam (1-2 mg), and they will be pre oxygenated 3-5 minutes before induction of anesthesia. General anesthesia will be given using propofol 2-3mg/kg intravenous(IV), fentanyl 1-2µg/kg IV and atracurium 0.5 mg/kg IV as a muscle relaxant to facilitate intubation. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Patients will be mechanically ventilated with 50% O2 and 50% air keeping end-tidal CO2 between 30 - 35 mmHg. Fentanyl bolus doses of 0.5-1 mcg/kg will be given according to the changes of hemodynamic variables more than 20% base line).

After the end of the surgery, and by the use of (Philips clear vue350, Philip Healthcare, Andover MAO1810, USA) ultrasound probe to perform the block according to the patient group.

Group Q: patients will receive qadratus lumborum block. The procedure will be performed under complete aseptic conditions, in the supine position, with slight elevation of the ipsilateral pelvis using a high frequency probe (5---10 MHz),connected to an ultrasound unit in transverse orientation. the probe will be positioned transversely at the anterosuperior iliac spine (ASIS) and it will be moved cranially to visualize the three muscle layers of the abdominal wall. After identifying the external oblique muscle, the probe will be moved posterolaterally to find its posterior border (hook sign) with the internal oblique muscle below it forming a roof above the quadratus lumborum muscle. By tilting the transducer down, the middle layer of the thoracolumbar fascia will be seen as a bright hyperechoic line. A 21-gauge Stimuplex® A 100-mm needle (B. Braun Melsungen AG, Germany) will be inserted in-plane in the anterolateral-to-posteromedial direction. After negative aspiration 0.2-0.4 ml/kg of bupivacaine 0.25% will be injected slowly on each side. Group R: patients will receive rectus sheath block. Under complete antiseptic condition,the rectus muscle will be identified using a high frequency linear probe with a transverse orientation placed across the abdomen above the level of the umbilicus. Starting with the midline, the linea alba and rectus muscle on either side will be identified. The rectus sheath will appear as hyperechoic fascial plane encircling the rectus abdominis muscle. Using an in-plane technique, the needle (100-mm needle ) will be passed through the rectus abdominal muscle to reach the plane between it and the posterior rectus sheath. After negative aspiration 0.2-0.4 ml/kg of bupivacaine 0.25% will be injected slowly on each side, local anaesthetic will be seen peeling the rectus muscle off the posterior rectus sheath.

At the end of surgery, all anesthetics will be stopped, reversal of muscle relaxants will be given, patients will be extubated when they will able to breath spontaneously with adequate tidal volume. Patients will be transferred to postanesthesia care unit (PACU). All patients will receive paracetamol 1gm/kg every 8 hours. All treating and outcome assessors staff will be blinded to the group allocation of the patients. At the recovery room, patients will assess their pain using VAS score, and they will be monitored for postoperative pain. Patients will be transferred to the ward and will leave the post anesthesia care unit (PACU) with Aldrete score more than 9. (14) patient with Vas score ≥4, will recieve a rescue dose of morphine 3-5 mg IV.

Being tested
Block
Keywords
quadratus lumborum block, rectus sheath block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BlockProcedure or surgery

    qadratus lumboroum (QL) block

Study groups in NCT06403020
Study groupRoleWhat they receive
Group QActive comparatorGroup Q (n=23) will have a qadratus lumboroum (QL) block.
Receives: Procedure: Block
Group RActive comparatorGroup R (n=23) will have a rectus sheath (RS) block.
Receives: Procedure: Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue score

    Postoperative pain

    Measured: The first 24 hours postoperative

Secondary outcomes (1)
  1. Age

    Demographic data

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start3 May 2024
  3. Primary completion15 Nov 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
In this randomized double blinded study, patients will be allocated randomly into two groups by a computer generated sequence using closed envelope method. Group Q (n=23) will have qadratus lumboroum (QL) block. Group R (n=23) will have rectus sheath (RS) block.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06403020
Sponsor's protocol ID
R321.
Status last verified
Mar 2025
First submitted
3 May 2024
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no plan to share

Publications

  • Karaarslan E, Topal A, Avci O, Tuncer Uzun S. Research on the efficacy of the rectus sheath block method. Agri. 2018 Oct;30(4):183-188. doi: 10.5505/agri.2018.86619.

    PubMed 30403273
  • Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

    PubMed 30688787

Questions about this trial

What is this clinical trial studying?

A study testing Block in people with Quadratus Lumborum Block and Rectus Sheath Block, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue score (time frame: The first 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06403020, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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