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

Primary Purpose

Anesthesia, Analgesia, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Subcostal Anterior Quadratus Lumborum Block
Thoracic Paravertebral Block
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia focused on measuring Regional Anesthesia, Acute Pain Scores, Subcostal Anterior Quadratus Lumborum Block, Thoracic Paravertebral Block, Morphine Consumption

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-III patients aged 18-75 y , scheduled for elective laparoscopic unilateral nephrectomy(partial / radical)

Exclusion Criteria:

  • Age <18y, >75y, ASA IV-V patients
  • 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

Sites / Locations

  • Ondokuz Mayis Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group S-QLB3

Group TPVB

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Post-operative acute pain
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.

Full Information

First Posted
December 29, 2021
Last Updated
March 17, 2023
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05191966
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Analgesia, Acute Pain, Patient Controlled Analgesia
Keywords
Regional Anesthesia, Acute Pain Scores, Subcostal Anterior Quadratus Lumborum Block, Thoracic Paravertebral Block, Morphine Consumption

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)'.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group S-QLB3
Arm Type
Active Comparator
Arm Description
S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA
Arm Title
Group TPVB
Arm Type
Active Comparator
Arm Description
TPVB block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA
Intervention Type
Procedure
Intervention Name(s)
Subcostal Anterior Quadratus Lumborum Block
Other Intervention Name(s)
S-QLB3
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thoracic Paravertebral Block
Other Intervention Name(s)
TPVB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine consumption in the first 24 hours after surgery
Description
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).
Time Frame
Postoperative Day 1
Secondary Outcome Measure Information:
Title
Post-operative acute pain
Description
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.
Time Frame
Postoperative Day 1
Other Pre-specified Outcome Measures:
Title
Patients' satisfaction and quality of pain management
Description
Patients' satisfaction and quality of pain management will be evaluated using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) -Turkish Version
Time Frame
Postoperative Day 1
Title
The number of patient required antiemetic
Description
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.
Time Frame
Postoperative Day 1
Title
Remifentanil consumption during the surgery
Description
The total amount of remifentanil consumed will be recorded.
Time Frame
The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 240 min
Title
Incidence of complications related to block
Description
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.
Time Frame
Postoperative 7 days on an average
Title
The incidence of side effects related to opioid use
Description
Complications related to opioid use such as pruritus, fatigue, sedation or respiratory depression will be recorded.
Time Frame
Postoperative Day 1
Title
The number of patient required rescue analgesia
Description
The number of patients requiring rescue analgesics will be recorded over 24 hours.
Time Frame
Postoperative Day 1
Title
The heart rate measurement
Description
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.
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.
Title
The mean arterial pressure measurement
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cengiz KAYA, MD
Organizational Affiliation
Ondokuz Mayıs University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayis Universitesi
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55139
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32753940
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.
Results Reference
background
PubMed Identifier
33762197
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.
Results Reference
background
PubMed Identifier
30659364
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.
Results Reference
background
PubMed Identifier
31412770
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.
Results Reference
background
PubMed Identifier
30688787
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.
Results Reference
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Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy

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