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Quadratus Lumborum Block III Versus Peritubal Local Infiltration

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quadratus block versus peritubal local infiltration
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patient with pelvic renal stone less than 2 cm
  • Americans society of Anesthesiologists physical status I, II
  • BMI<35

Exclusion Criteria:

  • patient refusal to participate in the study
  • Americans society of Anesthesiologists physical status III or above
  • major hepatic, renal or cardiovascular disease
  • BMI > 35
  • coagulopathy
  • psychological disorders.

Sites / Locations

  • Ain Shams University hosptal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Q

Group L

Arm Description

Patients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5%

Patients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5%

Outcomes

Primary Outcome Measures

Postoperative analgesia
Postoperative pain measured by visual analogue scale from 0 to 10 measured over 24h where 0 is better and 10 means worst pain
Analgesic requirement
Investigators measured the total dose of morphine consumption in mg over 24hour

Secondary Outcome Measures

Full Information

First Posted
December 28, 2019
Last Updated
November 4, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04215705
Brief Title
Quadratus Lumborum Block III Versus Peritubal Local Infiltration
Official Title
Postoperative Analgesic Efficiency of Quadratus Lumborum Block III Versus Peritubal Local Infiltration in Patients Undergoing exPercutaneous Percutaneous Nephrolithotomy Operation : a Randomized Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
July 12, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams 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
Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Q
Arm Type
Active Comparator
Arm Description
Patients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5%
Arm Title
Group L
Arm Type
Active Comparator
Arm Description
Patients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5%
Intervention Type
Procedure
Intervention Name(s)
Quadratus block versus peritubal local infiltration
Intervention Description
Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
Postoperative pain measured by visual analogue scale from 0 to 10 measured over 24h where 0 is better and 10 means worst pain
Time Frame
24 hours
Title
Analgesic requirement
Description
Investigators measured the total dose of morphine consumption in mg over 24hour
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patient with pelvic renal stone less than 2 cm Americans society of Anesthesiologists physical status I, II BMI<35 Exclusion Criteria: patient refusal to participate in the study Americans society of Anesthesiologists physical status III or above major hepatic, renal or cardiovascular disease BMI > 35 coagulopathy psychological disorders.
Facility Information:
Facility Name
Ain Shams University hosptal
City
Cairo
State/Province
Abbasya
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request from Corresponding Author
IPD Sharing Time Frame
Over 6 Within 6 month
IPD Sharing URL
http://www.synapse.org

Learn more about this trial

Quadratus Lumborum Block III Versus Peritubal Local Infiltration

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