NCT03973398

Brief Summary

  • Primary outcome: to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block.
  • Secondary outcome: to evaluate the efficacy of Quadratus Lumborum Block in the control of postoperative pain in patients undergoing Nephrectomy surgery, hemodynamics, any complications and patients' satisfaction..

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2020

Status
unknown

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

May 21, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

May 21, 2019

Last Update Submit

February 28, 2020

Conditions

Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (2)

  • Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Numeric Rating Scale.

    : to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by The Numeric rating scale (NRS) both resting and ambulatory which measures pain as felt by the patient every two hours for the first 24 hours then every six hours for the second day. the Numeric rating scale is a scale from 0 to 10 with '0' being lowest pain or no pain and '10' is the worst pain felt.

    baseline

  • Comparing the analgesic effects of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by using the Revised American Pain Society Patient Outcome Questionnaire.

    to compare the efficacy of Anterior subcostal versus Posterior approach in ultrasound guided Quadratus Lumborum Block by the Revised American Pain Society Patient Outcome Questionnaire which is a set of questions answered by the patient to evaluate the patient's satisfaction and for quality improvement of pain management in hospitalized patients

    baseline

Secondary Outcomes (1)

  • using the numeric rating scale to determine the effect of Quadratus Lumborum block in reducing the postoperative pain in patients undergoing nephrectomy surgery

    baseline

Study Arms (4)

Quadratus Lumborum Block anterior subcostal (QLa)

ACTIVE COMPARATOR

Patients in this group will receive Anterior subcostal Quadratus Lumborum block postoperative with 30 ml of 0.125 bupivacaine.

Procedure: Quadratus Lumborum block

Quadratus Lumborum Block posterior (QLp)

ACTIVE COMPARATOR

Patients in this group will receive Posterior Quadratus Lumborum block postoperative with 30 ml of 0.125 bupivacaine.

Procedure: Quadratus Lumborum block

Quadratus Lumborum Block anterior subcostal control (QLca)

PLACEBO COMPARATOR

Patients in this group will receive Anterior subcostal Quadratus Lumborum block postoperative with 30 ml of 0.9% normal saline.

Procedure: Quadratus Lumborum block

Quadratus Lumborum Block posterior control (QLcp)

PLACEBO COMPARATOR

Patients in this group will receive Anterior subcostal Quadratus Lumborum block postoperative with 30 ml of 0.9% normal saline.

Procedure: Quadratus Lumborum block

Interventions

Quadratus Lumborum blockPROCEDURE

ultrasound guided Quadratus Lumborum block for postoperative pain

Quadratus Lumborum Block anterior subcostal (QLa)Quadratus Lumborum Block anterior subcostal control (QLca)Quadratus Lumborum Block posterior (QLp)Quadratus Lumborum Block posterior control (QLcp)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both sex
  • Age: 18-60 years.
  • ASA I and II
  • Elective surgery

You may not qualify if:

  • Patient's refusal.
  • Allergy to local anesthetics.
  • Peripheral neuropathy.
  • Bleeding diathesis.
  • Inflammation or infection over injection site.
  • Morbid obesity.
  • Patients on previous opioid therapy.
  • Psychiatric disorders.
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Sherif Bekhet

CONTACT

00201155538773bekhetsherif89@gmail.com

Mohammed Mostafa

CONTACT

00201001123062Mo7_fathy@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 21, 2019

First Posted

June 4, 2019

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

March 3, 2020

Record last verified: 2020-02