NCT05822492

Brief Summary

In this study, it was aimed to evaluate the effects of anterior quadratus lumborum block (QLB3) and Erector Spina Plane Block (ESPB) on postoperative acute pain scores and opioid consumption in the first 24 hours in Percutaneous Nephrolithotomy Surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

April 10, 2023

Last Update Submit

December 2, 2023

Conditions

Keywords

AnesthesiaAnalgesiaPercutaneous Nephrolithotomy SurgeryPatient controlled analgesiaAnterior quadratus lumborum blockErector spina plane block

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption in the first 24 hours after surgery

    Morphine consumption in the first 24 hours after surgery will be measured. Patients will be able to request opioids via a PCA device when their NRS score is ≥ 4.

    postoperative day 1

Secondary Outcomes (8)

  • Postoperative pain scores

    postoperative day 1

  • The postoperative nausea and vomiting (PONV) scores and the number of patients requiring antiemetic medication.

    postoperative day 1

  • Intraoperative remifentanil consumption

    The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.

  • The number of patient required rescue analgesia

    postoperative day 1

  • Time of first analgesic request

    postoperative day 1

  • +3 more secondary outcomes

Study Arms (3)

Group QLB3

Patients who applied the QLB3 block before PCNL surgery were included in this group.

Procedure: Group QLB3

Group ESPB

Patients who applied ESP block before PCNL surgery were included in this group.

Procedure: Group ESPB

Group Control

Patients who did not use any block before PCNL surgery were included in this group.

Other: Group Control

Interventions

Group QLB3PROCEDURE

Patients who applied the QLB3 block before PCNL surgery were included in this group Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.

Also known as: Anterior Quadratus Lumborum Block (QLB3)
Group QLB3
Group ESPBPROCEDURE

Patients who applied ESP block before PCNL surgery were included in this group Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.

Also known as: Erector spina plane block (ESPB)
Group ESPB

Patients who did not use block before PCNL surgery were included in this group. Multimodal analgesia protocol is applied to all patients undergoing PCNL surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg after induction of general anesthesia and iv paracetamol 1 gr intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv PCA of 0,2mg/ml morphine (the bolus dose is 20 mcg/kg, the lock-in time of 6-10 minutes, and the 4-hour limit is adjusted to be 80% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥4), 100 mg tramadol is administered to patients. The prophylaxis for postoperative nausea and vomiting (PONV) involved the routine administration of 8 mg IV dexamethasone to patients before induction and 0.15 mg/kg IV ondansetron 20 minutes before the end of the procedure.

Also known as: Control
Group Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with undergoing percutaneous nephrolithotomy surgery,

You may qualify if:

  • years
  • American Society of Anesthesiology score I-III patients scheduled for unilateral PCNL in elective conditions
  • Patients with BMI \<35 kg/m2

You may not qualify if:

  • Pregnancy
  • Conditions where regional anesthesia is contraindicated (coagulopathy, international normalized ratio abnormality, thrombocytopenia, infection at the injection site)
  • History of hypersensitivity or allergy to local anesthetics
  • Patients with psychiatric disorders
  • Patients with musculoskeletal deformities
  • Patients with alcohol-drug dependence
  • Patients with cognitive dysfunction (patients incapable of evaluating the NRS score)
  • Patients who did not give consent / did not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz mayıs Universty

Samsun, 55060, Turkey (Türkiye)

Location

Related Publications (6)

  • Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen TF, Borglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy reduces opioid consumption and speeds ambulation and discharge from hospital: a single centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. doi: 10.1016/j.bja.2019.04.054. Epub 2019 May 30.

    PMID: 31153628BACKGROUND
  • Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.

    PMID: 28277325BACKGROUND
  • De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.

    PMID: 30621377BACKGROUND
  • Elsharkawy H. Quadratus Lumborum Blocks. Adv Anesth. 2017;35(1):145-157. doi: 10.1016/j.aan.2017.07.007. Epub 2017 Oct 3. No abstract available.

    PMID: 29103570BACKGROUND
  • Kilic E, Bulut E. Quadratus Lumborum Block III for Postoperative Pain After Percutaneous Nephrolithotomy. Turk J Anaesthesiol Reanim. 2018 Aug;46(4):272-275. doi: 10.5152/TJAR.2018.92331. Epub 2018 Aug 1.

    PMID: 30140533BACKGROUND
  • Turkan H, Kaya C, Turunc E, Dost B, Ustun YB. Effects of anterior quadratus lumborum block versus erector spinae plane block on postoperative acute pain in percutaneous nephrolithotomy: a prospective, observational study. BMC Anesthesiol. 2024 Sep 10;24(1):322. doi: 10.1186/s12871-024-02691-7.

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • CENGIZ KAYA

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 10, 2023

First Posted

April 20, 2023

Study Start

April 20, 2023

Primary Completion

September 20, 2023

Study Completion

September 30, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations