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

Primary Purpose

Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
control group
quadratus lumborum block type 3
erector spinae plane block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Disease focused on measuring erector spinae plane block, ,Quadratus Lumborum block, open nephrectomy, analgesia

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine, zagazig university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

QLB group

ESPB group

Arm Description

patients will be operated under general anesthesia.

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 erector spinae plane block with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Outcomes

Primary Outcome Measures

The 1st time to rescue analgesic
the time to ask for postoperative analgesia is the time from the end of operation to patient reporting VAS ≥ 3.

Secondary Outcome Measures

Visual analogue scale (VAS)
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Total dose of rescue analgesia (morphine)
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

Full Information

First Posted
April 21, 2020
Last Updated
April 20, 2021
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04361383
Brief Title
Erector Spinae Plane Versus Quadratus Lumborum Block for Patient Undergoing Open Nephrectomy
Official Title
Ultrasound-Guided Erector Spinae Plane Versus Quadratus Lumborum Block For Postoperative Analgesia for Patient Undergoing Open Nephrectomy: A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 12, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disease
Keywords
erector spinae plane block, ,Quadratus Lumborum block, open nephrectomy, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be divided randomly by a computer-generated randomization table into three equal groups
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
patients will be operated under general anesthesia.
Arm Title
QLB group
Arm Type
Active Comparator
Arm Description
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Arm Title
ESPB group
Arm Type
Active Comparator
Arm Description
patients will receive ultrasound-guided erector spinae plane block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
the patient will receive general anesthesia
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum block type 3
Other Intervention Name(s)
QLB
Intervention Description
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Other Intervention Name(s)
ESPB
Intervention Description
patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Primary Outcome Measure Information:
Title
The 1st time to rescue analgesic
Description
the time to ask for postoperative analgesia is the time from the end of operation to patient reporting VAS ≥ 3.
Time Frame
recorded within the first 24 hour postoperatively
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
Time Frame
measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively
Title
Total dose of rescue analgesia (morphine)
Description
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
Time Frame
in the first 24 hour postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of medicine, zagazig university
City
Zagazig
State/Province
Elsharqya
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
23860059
Citation
Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.
Results Reference
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PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
30393550
Citation
McCrum CL, Ben-David B, Shin JJ, Wright VJ. Quadratus lumborum block provides improved immediate postoperative analgesia and decreased opioid use compared with a multimodal pain regimen following hip arthroscopy. J Hip Preserv Surg. 2018 Oct 25;5(3):233-239. doi: 10.1093/jhps/hny024. eCollection 2018 Aug.
Results Reference
background
Citation
Niraj G, Tariq Z. Continuous Erector Spinae Plane (ESP) Analgesia In Different Open Abdominal Surgical Procedures: A Case Series. (2018) J Anesth Surg 5(1): 57- 60.
Results Reference
background
PubMed Identifier
28272292
Citation
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.
Results Reference
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Erector Spinae Plane Versus Quadratus Lumborum Block for Patient Undergoing Open Nephrectomy

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