Clinical trial NCT05191966: Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy
Official title: Comparison of the Effects of Subcostal Anterior Quadratus Lumborum Block and Thoracic Paravertebral Block on Postoperative Acute Pain in Laparoscopic Nephrectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Analgesia
Acute Pain
Patient Controlled Analgesia
Keywords: Regional Anesthesia
Acute Pain Scores
Subcostal Anterior Quadratus Lumborum Block
Thoracic Paravertebral Block
Morphine Consumption
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)'.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption in the first 24 hours after surgery
timeFrame: Postoperative Day 1
Secondary outcomes:
measure: Post-operative acute pain
timeFrame: Postoperative Day 1
Other outcomes:
measure: Patients' satisfaction and quality of pain management
timeFrame: Postoperative Day 1
measure: The number of patient required antiemetic
timeFrame: Postoperative Day 1
measure: Remifentanil consumption during the surgery
timeFrame: The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 240 min
measure: Incidence of complications related to block
timeFrame: Postoperative 7 days on an average
measure: The incidence of side effects related to opioid use
timeFrame: Postoperative Day 1
measure: The number of patient required rescue analgesia
timeFrame: Postoperative Day 1
measure: The heart rate measurement
timeFrame: 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.
measure: The mean arterial pressure measurement
timeFrame: 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.
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: Cengiz KAYA, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.