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NCT Number: NCT05191966

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

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.

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Key information

Conditions

Anesthesia Acute Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Controlled Analgesia Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

Laparoscopic partial or radical nephrectomy is associated with severe acute postoperative pain. Acute pain is mediated by inflammation, activation of spinal pathways and muscle spasm. Poor pain control may reduce patient satisfaction, delay postoperative ambulation and increase the incidence of pulmonary and cardiac complications.

Facial plane blocks, an important element of multimodal analgesia, can reduce the dosage of opioids, minimize side effects and improve the quality of postoperative recovery. Quadratus lumborum (QL) block is a relatively new technique. Subcostal anterior QL block (S-QLB3) involves injection in the plane between the psoas and QL muscles. Thoracic paravertebral block (TPVB) is frequently used in thoracic and general surgery and its significant analgesic efficacy has been demonstrated in the literature. It has been used successfully as part of multimodal analgesia in renal surgery.

In this study, it was aimed to evaluate the effects of S-QLB3 block and TPVB block on pain scores and opioid consumption in patients undergoing laparoscopic nephrectomy.

Patients will be divided into two groups:

Group S-QLB3:A unilateral S-QLB3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Group TPVB: A unilateral TPV block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400,000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: 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.

Other names: TPVB

Primary outcomes

  1. Morphine consumption in the first 24 hours after surgery

    Time frame: Postoperative Day 1

    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).

Secondary outcomes

  1. Post-operative acute pain

    Time frame: Postoperative Day 1

    Pain status at rest and while activity (coughing and deep breathing) will be assessed by NRS scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale which ranges from 0 to 10 at rest and during activity.

Other outcomes

  1. Patients' satisfaction and quality of pain management

    Time frame: Postoperative Day 1

    Patients' satisfaction and quality of pain management will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version

  2. The number of patient required antiemetic

    Time frame: Postoperative Day 1

    The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more is recorded, ondansetron 0,1 mg/kg iv will be administered.

  3. Remifentanil consumption during the surgery

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

    The total amount of remifentanil consumed will be recorded.

  4. Incidence of complications related to block

    Time frame: Postoperative 7 days on an average

    Complications associated with S-QLB3 and TPVB block (such as visceral organ injury, pneumothorax, retroperitoneal-paravertebral hematoma, lower extremity-quadriceps weakness, vascular puncture, epidural invasion, intrathecal injection and LAST) will be recorded.

  5. The incidence of side effects related to opioid use

    Time frame: Postoperative Day 1

    Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression will be recorded.

  6. The number of patient required rescue analgesia

    Time frame: Postoperative Day 1

    The number of patients requiring rescue analgesics will be recorded over 24 hours.

  7. The heart rate measurement

    Time frame: The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 200 min.

    The heart rate was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

  8. The mean arterial pressure measurement

    Time frame: The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit, up to 200 min.

    The mean arterial pressure was recorded preoperatively, one minute after the induction, and every 15-30 minutes until the patient was referred to the recovery unit.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Comparison of the Effects of Subcostal Anterior Quadratus Lumborum Block and Thoracic Paravertebral Block on Postoperative Acute Pain in Laparoscopic Nephrectomy Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 14, 2022
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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