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Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

Primary Purpose

Pain, Acute

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Bupivacaine

Lidocaine

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Extracorporeal Shockwave Lithotripsy, Quadratus Lumborum Block, bupivacaine, lidocaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Quadratus Lumborum Block

Group Control

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

Visual Analog Pain Score

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

Secondary Outcome Measures

Opioid consumption

Opioid consumption at 5.,10.,15., 20., 25., 30. minutes

Full Information

NCT ID

NCT03080363

First Posted

March 6, 2017

Last Updated

November 9, 2017

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT03080363

Brief Title

Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

Official Title

Is Painless ESWL Possible? Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During Extracorporeal Shockwave Lithotripsy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

May 15, 2017 (Actual)

Study Completion Date

June 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Acute

Keywords

Extracorporeal Shockwave Lithotripsy, Quadratus Lumborum Block, bupivacaine, lidocaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quadratus Lumborum Block

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group Control

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Intervention Description

10 ml %0.5 bupivacaine

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

10 ml %2 lidocaine

Primary Outcome Measure Information:

Title

Visual Analog Pain Score

Description

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

Time Frame

Intraoperative 30 minutes

Secondary Outcome Measure Information:

Title

Opioid consumption

Description

Opioid consumption at 5.,10.,15., 20., 25., 30. minutes

Time Frame

Intraoperative 30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Facility Information:

Facility Name

Ataturk University

City

Erzurum

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25886421

Citation

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.

Results Reference

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PubMed Identifier

25885985

Citation

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.

Results Reference

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Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL

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