Clinical trial NCT06386770: Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block
Official title: Systemic Versus Local Dexamedetomedine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block in Kidney Exploration Surgeries ,A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Erector Spinae Block
Dexmedetomidine
Keywords: Bupivacaine
kidney exploration surgery
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics.
timeFrame: at 60 , 180 minutes
Secondary outcomes:
measure: 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period .
timeFrame: at 1, 3, 6, 12, 24, 36 and 48 hours
measure: Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed
timeFrame: at 1, 3, 6, 12, 24, 36 and 48 hours
measure: Intraoperative hemodynamic parameters blood pressure
timeFrame: at 1, 3, 6, hours
measure: Minimum alveolar concentration (MAC) requirements
timeFrame: during intraoperative periods expressed in minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University
name: Rehab A Mahmoud, MSc
role: STUDY_CHAIR
affiliation: Aswan University
name: Ayman M Eldemrdash
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.