Erector Spinae Plane Versus Quadratus Lumborum Block for Patient Undergoing Open Nephrectomy

April 20, 2021 updated by: Shereen Elsayed Abd Ellatif, Zagazig University

Ultrasound-Guided Erector Spinae Plane Versus Quadratus Lumborum Block For Postoperative Analgesia for Patient Undergoing Open Nephrectomy: A Randomized Controlled Study.

The postoperative pain after open nephrectomy remains a major concern because some patients still demonstrate acute pain that may develop chronic pain that lasts for months following the surgery.

Epidural analgesia is the gold standard for abdominal surgery including for open nephrectomy, however, it has unfavorable side effects such as paresthesia, hypotension, hematomas, an impaired motor of lower limbs and urinary retention that could delay recovery.

Various techniques have tried to replicate the analgesic efficacy of epidural analgesia. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and transmuscular quadratus lumborum (TQL) analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries.

Up to the investigator's knowledge, there is no study done to compare ESPB versus QLB as pre-emptive analgesia in patients undergoing open nephrectomy.

Study Overview

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 [1]. 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 also reflexive muscle spasm. All of these three mechanisms of acute pain are typically ameliorated during the postoperative recovery [2].

Regional anesthesia techniques are commonly enhanced for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction [3].

Erector Spinae Plane block (RSPB), first described by Forero et al.,[4] for analgesia in thoracic neuropathic pain, has also been reported for the management of other causes of acute and postoperative pain [5,6,7]. In this ultrasound-guided (USG) technique, a local anesthetic (LA) is applied between the erector spinae muscle and the transverse process of the thoracic vertebra leading to the spread of LA cephalad, caudally and through the paravertebral space [4,5,8].

Quadratus Lumborum block (QLB) was initially described by R.Blanco as an abstract at the annual European Society of Regional Anaesthesia (ESRA) congress in 2007, where the LA was injected at the anterolateral aspect of the QL muscle (type 1 QLB) [9]. 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) [10]. 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 [11]. Finally, the intramuscular QLB (type 4 QLB) was done by injecting LA directly into the QL muscle [12].

The investigators hypothesize that performing ultrasound-guided ESPB block will be more superior to or equal to QLB in providing postoperative analgesia for patients undergoing open nephrectomy under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

    • Elsharqya
      • Zagazig, Elsharqya, Egypt, 44519
        • Faculty of medicine, Zagazig University

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

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient acceptance.
  • BMI ≤ 30 kg/m2
  • ASA II and III.
  • Elective open nephrectomy under general anesthesia

Exclusion Criteria:

  • History of allergy to the LA agents used in this study,
  • Skin lesion at the needle insertion site,
  • Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control group
patients will be operated under general anesthesia.
the patient will receive general anesthesia
ACTIVE_COMPARATOR: QLB group
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
  • QLB
ACTIVE_COMPARATOR: ESPB group
patients will receive ultrasound-guided erector spinae plane block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Other Names:
  • ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 1st time to rescue analgesic
Time Frame: recorded within the first 24 hour postoperatively
the time to ask for postoperative analgesia is the time from the end of operation to patient reporting VAS ≥ 3.
recorded within the first 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
Total dose of rescue analgesia (morphine)
Time Frame: in the first 24 hour postoperatively.
once the VAS score will be ≥ 3, rescue analgesia in the form of 0.1 mg/kg morphine will be given and the total dose consumed will be recorded
in the first 24 hour postoperatively.

Collaborators and Investigators

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

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.

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 (ACTUAL)

April 12, 2020

Primary Completion (ACTUAL)

August 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6004-12-4-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

planned after the completion of the study and publication

IPD Sharing Time Frame

planned after the completion of the study and publication

IPD Sharing Access Criteria

principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • 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

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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