Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy

NCT05191966 | Completed

• 1 other identifier: SAQLB-TPVB21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and thoracic paravertebral block (TPVB) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.

Conditions

Anesthesia; Analgesia; Acute Pain; Patient Controlled Analgesia

Keywords

Regional Anesthesia; Acute Pain Scores; Subcostal Anterior Quadratus Lumborum Block; Thoracic Paravertebral Block; Morphine Consumption

Outcome Measures

Primary Outcomes (1)

• Morphine consumption in the first 24 hours after surgery

  Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score is above 3 at rest and during activity (coughing and deep breathing).

  Postoperative Day 1

Secondary Outcomes (1)

• Post-operative acute pain

  Postoperative Day 1

Other Outcomes (8)

• Patients' satisfaction and quality of pain management

  Postoperative Day 1

• The number of patient required antiemetic

  Postoperative Day 1

• Remifentanil consumption during the surgery

  The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 240 min

Study Arms (2)

Group S-QLB3

ACTIVE COMPARATOR

S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA

Procedure: Subcostal Anterior Quadratus Lumborum Block

Group TPVB

ACTIVE COMPARATOR

TPVB block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA

Procedure: Thoracic Paravertebral Block

Interventions

Subcostal Anterior Quadratus Lumborum Block PROCEDURE

S-QLB3 block will be performed 30 min. before general anesthesia. For anterior QL block via subcostal approach, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the interfacial plane between the QLM and PMM. IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Also known as: S-QLB3

Group S-QLB3

Thoracic Paravertebral Block PROCEDURE

TPVB block will be performed 30 min. before general anesthesia. TPVB will be performed at T10 transverse process level, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the paravertebral space. IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Also known as: TPVB

Group TPVB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients aged 18-70 y, scheduled for elective laparoscopic unilateral nephrectomy(partial/radical)

You may not qualify if:

• Age \<18y, \>70y
• Obesity (BMI\> 30 kg / m2)
• Pregnancy
• Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
• Serious cardiac, hepatic, and cerebrovascular disease
• Hypersensitivity to local anesthetics or a history of allergy
• Patients with a history of opioid use longer than four weeks
• Patients with psychiatric disorders or communication difficulties
• Patients who do not want to participate
• Asthma/chronic obstructive pulmonary disease, chronic pain syndrome, substance use disorder, or sleep apnea

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (5)

• Kwak KH, Baek SI, Kim JK, Kim TH, Yeo J. Analgesic Effect of Ultrasound-Guided Preoperative Unilateral Lateral Quadratus Lumborum Block for Laparoscopic Nephrectomy: A Randomized, Double-Blinded, Controlled Trial. J Pain Res. 2020 Jul 3;13:1647-1654. doi: 10.2147/JPR.S257466. eCollection 2020.

  PMID: 32753940 BACKGROUND

• 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 BACKGROUND

• Elsharkawy H, Ahuja S, DeGrande S, Maheshwari K, Chan V. Subcostal approach to anterior quadratus lumborum block for pain control following open urological procedures. J Anesth. 2019 Feb;33(1):148-154. doi: 10.1007/s00540-018-02605-1. Epub 2019 Jan 18.

  PMID: 30659364 BACKGROUND

• Zhu M, Qi Y, He H, Lou J, Pei Q, Mei Y. Analgesic effect of the ultrasound-guided subcostal approach to transmuscular quadratus lumborum block in patients undergoing laparoscopic nephrectomy: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 14;19(1):154. doi: 10.1186/s12871-019-0825-4.

  PMID: 31412770 BACKGROUND

• 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.

  PMID: 30688787 BACKGROUND

MeSH Terms

Conditions

Agnosia; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Cengiz KAYA, MD

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio. A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the block/blocks about which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 14, 2022
• Study Start: September 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TU (1)