Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain ReliefFollowing Laparoscopic Nephrectomy

October 23, 2024 updated by: Asmaa Mohamed Hamza Sedky, Menoufia University

Ultrasound Guided Erector Spinae Block Versus Quadratus Lumborum Block For Postoperative Pain Relief After Laparoscopic Nephrectomy

The aim of this study is to assess the efficacy of Ultrasound guided erector spinae plane block versus quadratus lumborum block for postoperative analgesia in patient undergoing laparoscopic nephrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be a prospective randomized single-blind study. Patients will be randomized into two groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened before carrying out the block

The study will be conducted on 56 patients, 28 patients in each group:

Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) .

✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg)

Data Collection:

Baseline:

  1. Patient demographic data
  2. Hemodynamics (pulse- heart rate- mean blood pressure), baseline before induction of anesthesia.

Intraoperative:

  1. Hemodynamics (pulse- heart rate- mean blood pressure):

    They will be monitored and recorded 5 minutes after induction of anesthesia then every 30 min till end of the surgery.

  2. Total analgesic consumption needed to reach target Entropy measurement 40-60%.
  3. The anesthetic time (it is the time that starts when the anesthesia provider begins to administer the IV anesthetics and ends with tracheal extubation) and surgical time (starts with skin incision and ends with last suture and putting dressings on).
  4. The time taken to perform the block.
  5. Number of patients needed ephedrine and/or atropine and total amount of their administration will be recorded.
  6. Recovery time (time since anesthetics discontinuation till reaching score 9 of Alderete's criteria).

Postoperative:

  1. Time of first call for rescue analgesia.
  2. Number of patients requested analgesia postoperative.

  3. Visual analogue scale (VAS) on admission to post-anesthetic care unit (PACU), every 30 minutes for next 2 hours, every 2 hours for next 6 hours and every 4 hours for the rest of the 24 hours postoperatively.

    • Discharge from PACU will be according to Postanesthesia Discharge Scoring System[14](Appendix3).

  4. Hemodynamics (pulse- heart rate- mean blood pressure)

    They will be assessed as follow:

    • On admission to post-anesthetic care unit (PACU) then every 30 minutes at 30, 60, 90, 120 minutes then every 2 hours for next 6 hours then every 6 hours for remaining 24 hours.

  5. Vomiting, nausea and starting time of intestinal movements.
  6. Duration of the block (from the injection time of local anesthetic till complete return of sensation).

Study Type

Interventional

Enrollment (Actual)

56

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

  • Egypt
      • Shibīn Al Kawm, Egypt, 32511
        • Menoufia 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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I, II, III scheduled for laparoscopic nepheroctomy

Exclusion Criteria:

  • patient refusal bleeding disorders neurological and psychological diseases

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group Q
Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg)
Device: US guided block

Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) [9].

✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg
Experimental: group E
Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg)
Device: US guided block

Group Q; (28 patients) Quadratus lumborum block group; patients will receive general anesthesia initially then bilateral QLB type III (anterior subcoastal approach) with a volume of 30 mL of bupivacaine 0.25% for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg) [9].

✓ Group E; (28 patients) Erector spinae plane block; patients will receive general anesthesia initially then bilateral ESPB with a volume of 30 mL of bupivacaine 0.25 % for each side taking care that the patient does not receive a local anesthetic dose higher than the maximum allowed (2.5 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesia
Time Frame: 1 year
determine the time of first call for rescue analgesia
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time
Time Frame: 1 year
time taken to perform technique
1 year

Collaborators and Investigators

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

Sponsor

Menoufia University

Investigators

  • Study Director: Asmaa mohamed H Sedky, lectuerer of anathesia

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)

September 21, 2023

Primary Completion (Actual)

November 21, 2023

Study Completion (Actual)

October 21, 2024

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6/2023ANET44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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