NCT04215705

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2019

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

December 28, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

December 28, 2019

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Group Q

ACTIVE COMPARATOR

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

Procedure: Quadratus block versus peritubal local infiltration

Group L

ACTIVE COMPARATOR

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

Interventions

Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation

Group LGroup Q

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hosptal

Cairo, Abbasya, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 28, 2019

First Posted

January 2, 2020

Study Start

December 30, 2019

Primary Completion

July 12, 2020

Study Completion

July 15, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Upon request from Corresponding Author

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Over 6 Within 6 month
More information

Locations