Epidural Versus Quadratus Lamborum Block in Adult Open Nephrectomies

January 15, 2022 updated by: SABastawy, Assiut University

Epidural Versus Quadratus Lamborum Block for Postoperative Analgesia in Adult Open Nephrectomies : A Randomized Double Blind Controlled Trial

Our primary objective is to compare the effectiveness of bilateral QLB and epidural analgesia for postoperative management using VAS measured in PACU until 24 hours after surgery in patients undergoing elective open nephrectomies under GA. The secondary outcomes include: The 1st time to rescue analgesia and total amount of opioid consumption throughout the first postoperative day. hemodynamic variables. Any complications as postoperative nausea and vomiting (PONV) and sedation. The sensory block coverage & the Bromage score at 2, 6, 12, and 24 hours after anesthesia recovery and duration of urinary catheter usage. Duration of PACU stay and postoperative duration of hospitalization and Patients' satisfaction.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Open surgery remains basic surgery for patients requiring radical or partial nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. The physiopathology of acute pain is explained as it is mediated by inflammatory cell infiltration, activation of the pain pathways in the spinal cord, and reflexive muscle spasm. All these three mechanisms of acute pain are typically ameliorated during the postoperative recovery. Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction.

QLB has been introduced as a component of multimodal analgesia for thoracic and abdominal surgeries as:

cesarean section, hip arthroplasty, inguinal hernia repair and nephrectomies. It provides a great spread of local anesthesia which allows anesthesia from T6 - L2 and provides loss of somatic and visceral pain. The QLB was initially described by R.Blanco where the local anesthetic (LA) was injected at the anterolateral aspect of the QL muscle (type 1 QLB). Later, J.

Børglum used the posterior transmuscular approach by detecting Shamrock sign and injecting the LA at the anterior aspect of the QL (type 3 QLB). Recently, R. Blanco described another approach by injecting the LA at the posterior aspect of the QL muscle (type 2 QLB), which may be easier and safer as the LA is injected in a more superficial plane, so the risk of intra-abdominal complications and lumbar plexus injuries is less. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle. QLBs may be particularly useful in nephrectomy as it lacks the adverse effects associated with patient controlled analgesia including nausea, vomiting, sedation, and respiratory depression, as well as side effects of patient controlled epidural analgesia such as pruritus hypotension, and urinary retention. Our hypothesis is that performing ultrasound guided QLB will be more superior or equal to epidural block in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any patient fulfilling the inclusion criteria participating in our study .

Description

Inclusion Criteria:

  • Patients of American Society of Anesthesiologists (ASA) class I or II physical status.
  • Age:20-60 years old.
  • Patients scheduled for open nephrectomies .
  • Gender: both

Exclusion Criteria:

  • Patient refusal.
  • Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
  • Morbid obesity (BMI >35).
  • Patient with known hypersensitivity to amide local anesthetics or morphine.
  • Patient with any contraindication for intrathecal anesthesia, e.g. coagulopathy.
  • Psychiatric disorders, which will make observational pain intensity assessment difficult.
  • Pregnancy.
  • Skin lesions or wounds at the puncture site of the proposed block .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Epidural Block
Epidural block for the control group will be done before induction of general anesthesia. Patients will be positioned in the sitting position, an 18-gauge Tuohy needle will be inserted into epidural space of Th 11-12 intervertebral space under aseptic condition. In the medial approach, the site of the insertion of the needle is between the spaces created by the vertebral spinous processes. Upon locating the desired spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle
Quadratus Lumborum Block
Bilateral QL block type 3 (anterior) for the intervention group will be performed on both sides of the patient after induction of general anesthesia. Patient will be positioned in semi-lateral decubitus and using low-frequency ultrasonography (USG) guidance attached to inferior lumbar region (Petit's triangle) that is consisted of inferior iliac crest and bordered by two muscles such as latissimus dorsi muscle in the posterior, abdominal external oblique muscle in the anterior. The USG will display the Shamrock sign, where the transverse process of vertebrae L4 role as the trunk, erector spinae muscle on the posterior side, psoas major (PM) on the anterior side, and QL muscle on the lateral side. After the visualization of QL and PM muscles, the Contiplex R needle will be directed parallel to the posterior side of the ultrasound probe until the tip of needle is confirmed in the border of QL and PM muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the effectiveness of bilateral QLB and epidural analgesia
Time Frame: 24 hours
postoperative pain management using visual analog scale measured in postanesthesia care unit
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Kelani A. Abd El-Salam, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Open nephrectomies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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