Quadratus Lumborum Block Versus Thoracic Paravertebral Block

Ultrasound Guided Quadratus Lumborum Block Versus Thoracic Paravertebral Block in Gynacological Cancer Surgery

This study is to assess and compare the analgesic efficacy and safety of quadratus lumbotum block and paravertebral block in gynacological cancer patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Combination product: Ultrasound guided quadratus lumborum block; Combination product: Ultrasound guided thoracic paravertebral block

Detailed Description

All patients will be medically checked in the preoperative assessment clinic {history, physical examination, investigations (e.g. complete blood picture, coagulation profile , liver & kidney functions , ECG for patient above 40 years, chest x-ray for patients above 60 years and any other necessary investigations required for risky patients. ) }.

The patients will be randomly allocated into two equal groups(25 patients for each group) with a computer-generated list (www.Random.org).

QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg & 3mg/Kg with epinephrine).

PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10.

• In the recovery room, the patients will be continuous monitored for pulse, blood pressure, oxygen saturation.
• Humidified oxygen 3L/min. by nasal prong will be delivered to all patients.
• Portable ultrasound machine , nerve stimulator, pressure injector monitor ,resuscitation equipment &drugs (e.g. epinephrine, lipid emulsion ), sterile gloves and surgical towels should be available.
• Intravenous(IV) 18 gauge cannula will be inserted. Midazolam 0.02 mg/Kg will be administered.

While the patients in the supine or lateral position, they will receive bilateral single injection ultrasound guided QLBs under complete sterilization of the abdomen with sterile solution (iodine povacryl & isopropyl alcohol solution). All patients will be monitored throughout the performance of the block & all data will be recorded. A linear ultrasound transducer probe (6-13MHZ), or curved probe (according to patients BMI). ( Sonosite M-turbo; Inc., Bothell, WA, USA) in a sterile cover will be placed at the level of the anterosuperior iliac spine and moved cranially until the three muscle layers of the abdomen will be identified: external oblique, internal oblique, and transversus abdominis muscles. The external oblique muscle will be followed posterolaterally until its posterior border visualize (hook sign) leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that corresponded with the intermediate layer of the thoracolumber fascia(Blanco et al.,2015).

A 21 gauge blunt, insulated, echogenic needle will be inserted in plane . The optimal point of injection will be determined using hydrodissection (3-5 mL normal saline). The site of the needle will be confirmed in place by ultrasound guided, nerve stimulator (B- Braun) & pressure injector monitor.

After negative aspiration, we will inject 0.3mL/Kg bupivacaine 0.25% in each side in QLB group. The patients will be monitored for about 20-30 minutes before induction of anesthesia.

While the TPVB will be performed by single injections at the level of T10 vertebra. The patients will be placed in the sitting position, and the spinal process of T10 will be palpated. Then a linear ultrasound transducer probe (6-13 MHZ).

( Sonosite M-turbo; Inc., Bothell, WA, USA) in a sterile cover will be placed at the corresponding transverse process to be clearly visualized and the skin-transverse process distance will be measured on both sides. After infiltration of the skin and subcutaneous tissue with 1% lidocaine with epinephrine 5ug/ml, an 18G Touphy needle will be inserted perpendicular to the skin, approximately 2.5 cm from midline, until contact with the transverse process will be established ( It is important to visualize the pleura very clearly at all times ). The needle will then slightly withdrawal & reinserted 1-1.5 cm deeper either caudally or cranially for the transverse process (TP). The site of the needle will be confirmed in place by ultrasound guided, nerve stimulator (B- Braun) & pressure injector monitor.

After careful aspiration, patients will be received a slow injection of 0.25mL/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml at the level of T10. The patients will be monitored for about 30 minutes before induction of anesthesia. Induction of general anesthesia will be done.

After full awakening from anesthesia, the patient will be transferred to the recovery room. In the recovery room, the patient will be continuous monitored & humidified oxygen will be applied for about 1 hour. Then a standardized analgesic regimen consisting of regular IV/oral paracetamol 1g every 6 hours combined with PCA morphine (on demand) will be initiated. Patients required additional analgesia will be received IV ketorolac(15-30mg).

A trained anesthetist not involved in the study & blinded to the patient group will measure the VAS, morphine requirements & patient satisfaction.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma G Hussein, master; Phone Number: 00201023431090; Email: fatmagomaa54p@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

1. Inclusion criteria

1. ASA I-III.
2. Age ≥ 20 & ≤ 70
3. Body mass index (BMI): Less than forty and more than twenty.
4. Patients undergoing major gynacological cancer surgeries.

2. Exclusion criteria

1. Patient refusal.
2. History of sensitivity to local anesthetic (amide group).
3. History of psychological disorders.
4. Coagulopathies: hereditary (e.g. hemophilia, fibrinogen abnormalities& deficiency of factor II) - acquired (e.g. liver disease, vitamin K deficiency & therapeutic anticoagulants drugs).
5. Localized infection.
6. Morbid obese BMI>40.
7. Incooperative patients.
8. Patients on chronic pain therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Quadratus lumborum block; QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg & 3mg/Kg with epinephrine), single injection sonar guided.	Combination product: Ultrasound guided quadratus lumborum block; prospective randomized comparative study between Group (1) : quadratus lumborum block; Other Names: QLB
EXPERIMENTAL: Thoracic paravertebral block; PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided.	Combination product: Ultrasound guided thoracic paravertebral block; PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided.; Other Names: PVB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	Pain score will be measured according to severity	Baseline pain till first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine demands postoperative	The amount of morphine required to relieve pain will be recorded	First 24 hours postoperative
Patient satisfaction	Patient satisfaction measured by visual analogue score	First 24 hours postoperative

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Director: Khaled A El-samahy, Professor, National Cancer Institute (NCI); Study Director: Ekramy M Abd-elghaffar, MD, National Cancer Institute (NCI); Study Director: Esam Ab Mahran, MD, National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.
• Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495. Erratum In: Reg Anesth Pain Med. 2018;43:111.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): July 30, 2021
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Thoracic paravertebral block; Postoperative analgesia; Quadratus lumborum block
• Other Study ID Numbers: Quadratuslumborum block & TPVB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Starting in April 2021 Ending in July 2021
• IPD Sharing Time Frame: Immediately after publication No end date
• IPD Sharing Access Criteria: Any one who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No