EOINBvsESB: Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy

Sponsor
Menoufia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06048744
Collaborator
(none)
25
1
2
4
6.2

Study Details

Study Description

Brief Summary

The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive U S guided external oblique intercostal block after induction.

Group B:

Patients will receive US guided erector spine block after induction.

Condition or Disease Intervention/Treatment Phase
  • Procedure: external oblique intercostal block
  • Procedure: Erector Spine block
N/A

Detailed Description

Patients will be premedicated with IV midazolam (0.05 mg/kg). Under standard monitoring including Electrocardiography, Non-Invasive Blood Pressure, and Pulse Oximetry. General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98%. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcoastal Nephrectomy: A Randomised Trial
Actual Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: external oblique intercostal block

After induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted. A 14-15 MHz linear ultrasound transducer (Sono-Site) was placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 30 ml of bupivacaine 0.25% will be administered incrementally. The drug will be injected after a negative aspiration into the plane deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles.

Procedure: external oblique intercostal block
U S guided external oblique intercostal block after induction.

Active Comparator: Erector Spine Block

After induction of general anesthesia, patients will be positioned in the lateral position . A linear ultrasound transducer will be placed on the midline to identify the T8 spinous process. From this position, the ultrasound transducer was moved 2-3 cm laterally to visualize the hyperechoic line of the T8 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. 30 ml 0.25% bupivacaine will be injected.

Procedure: Erector Spine block
US guided erector spine block after induction

Outcome Measures

Primary Outcome Measures

  1. time for first rescue analgesia [day 0]

    hours

Secondary Outcome Measures

  1. visual analogue score VAS score [24 hours]

    (a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)

  2. the number of rescue analgesics [24hours]

    numbers'

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I& II&III scheduled for elective (Subcostal) Nephrectomy
Exclusion Criteria:
  • Patients who are:

  • Uncooperative.

  • Having allergy to any of the study drugs.

  • Known abuse of alcohol or medication.

  • Having Local infection at the site of injection or systemic infection.

  • Pregnancy.

  • With coagulation disorders or on anticoagulation therapy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Menoufia university Cairo Shibin Elkom Egypt

Sponsors and Collaborators

  • Menoufia University

Investigators

  • Principal Investigator: AMAL G SAFAN, MD, Menoufia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amal Gouda Elsayed Safan, lecturer of anaethesia, Menoufia University
ClinicalTrials.gov Identifier:
NCT06048744
Other Study ID Numbers:
  • 9/2023ANET1-2
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023