Dexamethasone Versus Mg Added to Bupivacaine Used in ESPB for Perioperative Pain Control in Patients Undergoing Unilateral Nephrectomy

NCT06501079 | Recruiting DMC

• 1 other identifier: AP2404-201-004
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study: The current study aims to compare the effect of adding dexamethasone versus magnesium sulfate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain. Primary Objectives: \- To compare the effect of ESPB without additives to the effect of adding dexamethasone and to the impact of adding magnesium sulfate in the form of post-operative morphine consumption

Conditions

Renal Neoplasm

Keywords

Dexamethasone; Magnesium Sulphate; Bupivacaine; Erector Spinae Plane Block; perioperative; pain control; unilateral nephrectomy

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  total postoperative rescue analgesia be by Morphine

  24 hours post-operatively

Secondary Outcomes (3)

• time of first rescue analgesia

  during 1st 24 postoperatively.

• Intraoperative opioid consumption

  intraoperative

• visual analogue scale 30 hours post-operatively at rest

  24 hours post-operatively at rest

Study Arms (3)

Normal saline

ACTIVE COMPARATOR

receiving erector spinae block with 27ml bupivacaine 0.25% + 3 ml NS

Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%

magnesium sulphate 10%

ACTIVE COMPARATOR

receiving erector spinae block with 27 ml bupivacaine 0.25% + 3 ml magnesium sulphate 10%

Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%

dexamethasone

ACTIVE COMPARATOR

receiving erector spinae block with 27 ml bupivacaine 0.25% + 8 mg dexamethasone (2 ml) + 1 ml NS.

Procedure: ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25%

Interventions

ultrasound guided Erector Spinae Plane Block using 27ml bupivacaine 0.25% PROCEDURE

ESP block will be performed U/S at the level of T 10 paraspinal level. The ultrasound transducer should be placed in the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. Erector spinae muscle should be identified superficial to the transverse process. The needle inserted superior to the ultrasound probe in the cephalad to caudal direction. Once the needle tip is below the erector spinae muscle. This separation from the transverse process confirms the proper needlemposition. The local anesthetic should then be injected in 5 ml increments. The block will be performed preoperatively.

Normal saline; dexamethasone; magnesium sulphate 10%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 - 65)
• Patients undergoing unilateral nephrectomy
• ASA II / III

You may not qualify if:

• Patient refusal
• Age less than 18 years
• Allergy to any of the studied medications
• Mid line incision
• Bilateral nephrectomy
• Distorted anatomy of the back (e.g. kyphoscoliosis)
• Known neurologic disorders, psychiatric disorder or chronic pain
• Local infection
• Hemodynamic instability

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer institute - Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ahmed M Soliman

CONTACT

01286979695; ams21787arif@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Model Details: The aim of the current study is to compare the effect of adding dexamethasone versus magnesium sulphate to bupivacaine in ultrasound-guided erector spinae plane block on the severity of postoperative pain. Primary Objectives to compare the effect of ESPB without additives to the effect of adding dexamethasone and to the effect of adding magnesium sulphate in the form of post-operative visual analogue scale (VAS) after 30 hours at rest.

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 15, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

EG (1)