Quadratus Lumborum Block III Versus Peritubal Local Infiltration

Postoperative Analgesic Efficiency of Quadratus Lumborum Block III Versus Peritubal Local Infiltration in Patients Undergoing exPercutaneous Percutaneous Nephrolithotomy Operation : a Randomized Comparative Study

Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Quadratus block versus peritubal local infiltration

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasya
    • Cairo, Abbasya, Egypt
      • Ain Shams University hosptal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Q; Patients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5%	Procedure: Quadratus block versus peritubal local infiltration; Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation
Active Comparator: Group L; Patients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5%	Procedure: Quadratus block versus peritubal local infiltration; Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours
Analgesic requirement	Investigators measured the total dose of morphine consumption in mg over 24hour	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Actual): July 12, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Post PCNL analgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon request from Corresponding Author

IPD Sharing Time Frame

Over 6

Within 6 month

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No