NCT05860309

Brief Summary

A multimodal analgesia regimen is suggested after nephrectomy, although some patients still report agonising pain. Regional anesthesia approaches may improve postoperative pain management and reduce the requirement for opioids after renal surgery.QLB provides early and rapid pain relief

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 6, 2023

Last Update Submit

May 6, 2023

Conditions

Keywords

multimodal analgesia, regional blocks, renal surgeries

Outcome Measures

Primary Outcomes (1)

  • The time to first postoperative rescue analgesia.

    the first time patient ask for analgesia

    postoperative 24 hours

Secondary Outcomes (1)

  • total consumption of opioid in first 24 hours

    first 24 hours postoperatively

Study Arms (2)

preoperative quadratous lumborum block

ACTIVE COMPARATOR

patients weill recieve preoperative ultrasound guided quadratous lumborum block at lateral position before start of surgery after induction of general anesthesia

Other: quadratous lumborum block

postoperative quadratous lumborum block

ACTIVE COMPARATOR

patients weill recieve postoperative ultrasound guided quadratous lumborum block at lateral position at the end of surgery before recovery from general anesthesua

Other: quadratous lumborum block

Interventions

The patient will be placed in the lateral position, after sterilization.. QLB will be done using ultrasound, The probe will be positioned superior to the iliac crest, in the transverse orientation, at the posterior axillary line. The Shamrock sign will be identified at the L4 level, and the insulated nerve block needle will be advanced from posterior to anterior, through the QL muscle, until the needle tip is visualized in the interfascial plane between the QL muscle and psoas muscle. As the correct needle placement is confirmed with 2-3 mL of saline, 20 mL of 0.25% bupivacaine will be injected ensuring that the psoas muscle will be pushed deeply.

Also known as: myofascial block
postoperative quadratous lumborum blockpreoperative quadratous lumborum block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • o Patients aged between 18 - 60 years old.
  • Both sexes.
  • Physical Status: ASA I and II.

You may not qualify if:

  • o Refusal of procedure or participation in the study .
  • Physical status: ASA III or above .
  • Infection at site of injection.
  • Psychiatric illness .
  • CNS Diseases like epilepsy, stroke …etc.
  • History or evidence of coagulopathy .
  • Allergies to drug used (Bupivacaine 0.5%).
  • Patients who suffered from allergy to local anesthetics .
  • Difficult visualization of the anatomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ainshams hospitals

Cairo, 11591, Egypt

Location

Related Publications (1)

  • Borys M, Szajowska P, Jednakiewicz M, Wita G, Czarnik T, Mieszkowski M, Tuyakov B, Galkin P, Rahnama-Hezavah M, Czuczwar M, Piwowarczyk P. Quadratus Lumborum Block Reduces Postoperative Opioid Consumption and Decreases Persistent Postoperative Pain Severity in Patients Undergoing Both Open and Laparoscopic Nephrectomies-A Randomized Controlled Trial. J Clin Med. 2021 Aug 15;10(16):3590. doi: 10.3390/jcm10163590.

    PMID: 34441884BACKGROUND

Study Officials

  • sanaa F wasfy

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wael S Abdelmegied

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: preoperative versus postoperative quadratous lumborum block in nephrectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia and intensive care

Study Record Dates

First Submitted

May 6, 2023

First Posted

May 16, 2023

Study Start

June 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations