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

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04361383
Collaborator
(none)
75
1
3
4.7
16.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: control group
  • Procedure: quadratus lumborum block type 3
  • Procedure: erector spinae plane block
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patients will be divided randomly by a computer-generated randomization table into three equal groupsThe patients will be divided randomly by a computer-generated randomization table into three equal groups
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound-Guided Erector Spinae Plane Versus Quadratus Lumborum Block For Postoperative Analgesia for Patient Undergoing Open Nephrectomy: A Randomized Controlled Study.
Actual Study Start Date :
Apr 12, 2020
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control group

patients will be operated under general anesthesia.

Other: control group
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.

Procedure: quadratus lumborum block type 3
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.

    Procedure: erector spinae plane block
    patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
    Other Names:
  • ESPB
  • Outcome Measures

    Primary Outcome Measures

    1. The 1st time to rescue analgesic [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.

    Secondary Outcome Measures

    1. Visual analogue scale (VAS) [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.

    2. Total dose of rescue analgesia (morphine) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine, zagazig university Zagazig Elsharqya Egypt 44519

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shereen Elsayed Abd Ellatif, lecturer of anesthesia and surgical intensive care, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT04361383
    Other Study ID Numbers:
    • 6004-12-4-2020
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shereen Elsayed Abd Ellatif, lecturer of anesthesia and surgical intensive care, Zagazig University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 21, 2021