NCT03080363

Brief Summary

Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract calculi; however, the vast majority of patients do not tolerate the procedure without analgesia and sedation. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine cream). The quadratus lumborum block was first described by Blanco. QL block is performed as one of the perioperative pain management procedures for abdominal surgery. QL block provides anesthesia and analgesia on the anterior and lateral wall of the abdomen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

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

March 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

March 6, 2017

Last Update Submit

November 9, 2017

Conditions

Keywords

Extracorporeal Shockwave LithotripsyQuadratus Lumborum Blockbupivacainelidocaine

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Pain Score

    Visual Analog Pain Score at 5.,10.,15., 20., 25., 30. minutes

    Intraoperative 30 minutes

Secondary Outcomes (1)

  • Opioid consumption

    Intraoperative 30 minutes

Study Arms (2)

Quadratus Lumborum Block

ACTIVE COMPARATOR

Ultrasound guided Quadratus Lumborum Block with 10 ml %0.5 bupivacaine and 10 ml %2 lidocaine

Drug: BupivacaineDrug: Lidocaine

Group Control

NO INTERVENTION

No intervention

Interventions

10 ml %0.5 bupivacaine

Quadratus Lumborum Block

10 ml %2 lidocaine

Quadratus Lumborum Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

You may not qualify if:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

  • Elnabtity AM, Tawfeek MM, Keera AA, Badran YA. Is unilateral transversus abdominis plane block an analgesic alternative for ureteric shock wave lithotripsy? Anesth Essays Res. 2015 Jan-Apr;9(1):51-6. doi: 10.4103/0259-1162.150177.

    PMID: 25886421BACKGROUND
  • Hanoura S, Elsayed M, Eldegwy M, Elsayed A, Ewieda T, Shehab M. Paravertebral block is a proper alternative anesthesia for outpatient lithotripsy. Anesth Essays Res. 2013 Sep-Dec;7(3):365-70. doi: 10.4103/0259-1162.123238.

    PMID: 25885985BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

BupivacaineLidocaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 15, 2017

Study Start

March 15, 2017

Primary Completion

May 15, 2017

Study Completion

June 5, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations