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

NCT04361383 | Completed

• 1 other identifier: 6004-12-4-2020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Disease

Keywords

erector spinae plane block; ,Quadratus Lumborum block; open nephrectomy; analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  recorded within the first 24 hour postoperatively

Secondary Outcomes (2)

• Visual analogue scale (VAS)

  measured at at 1 hour, 2,4,,8,12,18, 24 hour postoperatively

• Total dose of rescue analgesia (morphine)

  in the first 24 hour postoperatively.

Study Arms (3)

Control group

PLACEBO COMPARATOR

patients will be operated under general anesthesia.

Other: control group

QLB group

ACTIVE COMPARATOR

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

ESPB group

ACTIVE COMPARATOR

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

Interventions

control group OTHER

the patient will receive general anesthesia

Control group

quadratus lumborum block type 3 PROCEDURE

patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Also known as: QLB

QLB group

erector spinae plane block PROCEDURE

patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.

Also known as: ESPB

ESPB group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (5)

• 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.

  PMID: 23860059 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30393550 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28272292 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: The patients will be divided randomly by a computer-generated randomization table into three equal groups

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: April 12, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 21, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)