Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block

NCT ID: NCT06386770

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-03-01

Brief Summary

The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.

Detailed Description

Open Kidney surgeries remain one of the approaches used for those patients are requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain for months following surgery.

Effective treatment of postoperative pain allows early mobilization of the patient, shortens the recovery and discharge time, prevents the development of chronic pain, and increases satisfaction and long-term quality of life.

Current modalities used to manage pain for patients undergoing kidney exploration include oral and parenteral opioid administration, local anesthetic infiltration, and certain neuraxial and regional anesthesia procedures including thoracic epidurals and paravertebral blocks.

The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients, and it is performable with minimal or no sedation in the pre-operative holding area.

Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications.

The local anesthetic drugs have a limited duration of action, so we need to add adjuvants such as opioids, alpha two agonists, neostigmine, or magnesium.

Dexmedetomidine is a potent α2 agonist and is a powerful adjuvant to regional anesthesia and analgesia. It can prolong the duration of the nerve block anesthesia resulting in increased effectiveness of the block in terms of duration, less use of opioids, and shorter hospital stay in the absence of clinically significant side effects (hypotension, nausea, vomiting, and pruritus.

Adding adjuvants to local anesthetics is frequently used to prolong the duration of single-injection regional nerve block.

There have been multiple studies claiming increased effectiveness of use of dexmedetomidine and this has been consolidated in a meta-analysis examining the effectiveness of dexamedetomedine as a peripheral nerve block adjuvant.

Conditions

Erector Spinae Block; Dexmedetomidine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group Ι Block only (group BO) (control group)

Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: DRUG

.Group Ι Block only (group BO) (control group): erector spinae block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Group ΙI (group DL):

Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexmedetomidine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9%) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type: DRUG

Group ΙI (group DL): erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexamedetomedine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9% ) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Group III (group D IV):

Ultrasound guided erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexmedetomidine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Intervention Type: DRUG

Group III (group D IV): erector spinea block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexamedetomedine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia.

Interventions

Dexmedetomidine Injection [Precedex]

Group ΙI (group DL): erector spinae block will receive 30 ml (28 ml bupivacaine 0.25% plus dexamedetomedine (0.5µg/kg) diluted in 2ml normal saline Na cl 0,9% ) + 10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Intervention Type: DRUG

Bupivacaine Hydrochloride

.Group Ι Block only (group BO) (control group): erector spinae block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9 %) +10ml IV normal saline will be injected over 10 min after 10 min from the induction of general anesthesia

Intervention Type: DRUG

Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)

Group III (group D IV): erector spinea block will receive 30 ml ( 28 ml bupivacaine 0.25% +2ml normal saline Na cl 0,9%) + dexamedetomedine (0.5µg/kg) diluted with 10 ml normal saline IV infusion by syringe pump over 10 min after 10 min from the induction of general anesthesia.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

•. kidney exploration surgeries.

• ASA I/II patients.
• BMI <35

Exclusion Criteria

• Getting opioid analgesics prior to surgery.
• Local infections at the site where needle for block is to be inserted.
• ASAIII/IV.
• Pregnancy.
• History of drug addiction or alcohol abuse or a psychiatric illness,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aswan University

OTHER

Sponsor Role: lead

Responsible Party

Soudy Salah Hammad

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehab A Mahmoud, MSc

Role: STUDY_CHAIR

Aswan University

Ayman M Eldemrdash

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Locations

Aswan University

Aswān, Aswan Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Tarek s Hemaida, MD

Role: CONTACT

dr.tarek@aswu.edu.eg

0100 736 3190

Soudy s Hammad, MD

Role: CONTACT

soudi.salah@aswu.edu.eg

+201014761523

Facility Contacts

soudy S hammad

Role: primary

soudi.salah@aswu.edu.eg

+201014761523

tarek S hemaida

Role: backup

dr.tarek@aswu.edu.eg

01007363190

References

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.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

Wang Q, Li H, Wei S, Zhang G, Ni C, Sun L, Zheng H. Dexmedetomidine Added to Ropivacaine for Ultrasound-guided Erector Spinae Plane Block Prolongs Analgesia Duration and Reduces Perioperative Opioid Consumption After Thoracotomy: A Randomized, Controlled Clinical Study. Clin J Pain. 2021 Oct 12;38(1):8-14. doi: 10.1097/AJP.0000000000000992.

Reference Type: BACKGROUND

PMID: 34636753 (View on PubMed)

Other Identifiers

Asw.U./742 /2/23

Identifier Type: -

Identifier Source: org_study_id