Quadratus Lumborum Block (Transmuscular Approach) VS. TransversusAbdominus Plane Block(Unilateral Posterior Approach) for Perioperative Analgesia in Patients Undergoing Flank Incision Surgeries.

NCT03744923 | Completed

• 1 other identifier: N-36-2018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Severe perioperative pain experienced after surgical procedures performed by flank incision is mainly related to incision of many muscles. Postoperative pain affects patient comfort, satisfaction, prolongs the duration of hospital stay and increases post-procedure complications. This study is designed to compare the success rate of Unilateral Ultrasound Guided Transmuscular Quadratus Lumborum Block with Unilateral posterior Ultrasound Guided TransversusAbdominus Plane block in providing perioperative analgesia in Patients undergoing Flank Incision surgeries in the Urosurgery Theater at KasrAlainy University Hospitals.

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• fentanyl consumption in the intraopertive period

  Measurement of total the amount of fentanyl consumption in the intraopertive period in the three allocated groups as indicator for hemodynamic stability and efficacy of both types of blocks.

  3 hours

Secondary Outcomes (2)

• doses of postoperative mepridine analgesics

  24 hours

• VAS(visual analogue score)

  24 hours

Study Arms (3)

Transmuscular QLB group

ACTIVE COMPARATOR

Ultrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall Then, scan dorsally keeping the transverse orientation until observing that the transverse abdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia The needle (20G spinal needle) is inserted in-plane from posterior to anterior and the tip of the needle is advanced towards then through the QL muscle, penetrating the ventral proper fascia of the QL muscle. The target site for injection is the plane between quadratus lumborum and psoas major. This will be followed by injection of Bupivacaine 0.5 % (0.25ml/kg) and lidocaine 2% (0.15ml/kg) mixed together.

Procedure: transmuscular QL block

unilateral posterior TAP block group

ACTIVE COMPARATOR

under ultrasonographic guidance,the probe will be positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line. Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid-axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, the block was performed with the 20G spinal needle. The needle will be directed to approach the TAP with "in-plane" USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydro visualization of needle-tip position and confirming its correct positioning. This will be followed by injection of Bupivacaine 0.5 % (0.25ml/kg) and lidocaine 2% (0.15ml/kg) mixed together.

Procedure: Transversus Abdominus Plane block

control group

NO INTERVENTION

the patients will not receive any blocks

Interventions

transmuscular QL block PROCEDURE

Ultrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall. Then, scan dorsally keeping the transverse orientation until observing that the transversusabdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle. The view of the psoas major muscle (PM) anteriorly, the erector spinae muscle (ESM) posteriorly and the QL muscle adherent to the apex of the transverse process result in a well recognizable pattern of a Shamrock with three leaves (trifoliate).

Transmuscular QLB group

Transversus Abdominus Plane block PROCEDURE

Posterior TAP block will be performed on the same side of surgery (unilateral) under ultrasonographic guidance with a with broadband (7-13MHz) linear probe covered with a sterile plastic sheath. Probe will positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line. Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, block was performed with 20G spinal needle. The needle will be directed to approach the TAP with "in-plane" USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydrovisualization of needle-tip position and confirming its correct postioning.

unilateral posterior TAP block group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age between \>20 and \<60.
• Patients scheduled for Urological flank surgery (open nephrectomy)
• Ability to sign the consent
• ASA classification I, II
• Body Mass Index (BMI) \< or = 30
• Duration of surgery less than 3 hours

You may not qualify if:

• Refusal of the regional block.
• Bleeding disorders (INR \>1.4 )( platelet count \<100,000/mm3 )
• Skin lesions or infection at the site of proposed needle insertion.
• Evidence of peritonitis or septicemia.
• Hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
• Patients with ventriculoperitoneal shunts in situ.
• Allergy to amide local anesthetics, fentanyl or meperidine.
• Patients suffering from neurological disease.
• ASA classification \> II
• BMI \> 30
• Duration of surgery more than 3 hours

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amany Hassan Saleh

Giza, 02, Egypt

Location

Related Publications (1)

• Saleh AH, Abdallah MW, Mahrous AM, Ali NA. Quadratus lumborum block (transmuscular approach) versus transversus abdominis plane block (unilateral subcostal approach) for perioperative analgesia in patients undergoing open nephrectomy: a randomized, double-blinded, controlled trial. Braz J Anesthesiol. 2021 Jul-Aug;71(4):367-375. doi: 10.1016/j.bjane.2021.01.009. Epub 2021 Mar 21.

  PMID: 33762197 DERIVED

Study Officials

• kasr alaini hospital

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 19, 2018
• Study Start: November 20, 2018
• Primary Completion: September 20, 2019
• Study Completion: October 1, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)