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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06386770
Other study ID # Asw.U./742 /2/23
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 1, 2023
Est. completion date June 1, 2024

Study information

Verified date May 2024
Source Aswan University
Contact Tarek s Hemaida, MD
Phone 0100 736 3190
Email dr.tarek@aswu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine Injection [Precedex]
Group ?I (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
Bupivacaine Hydrochloride
.Group ? 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
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.

Locations

Country Name City State
Egypt Aswan University Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics. The duration of analgesia, this was defined as the time in minutes to the first request for at 60 , 180 minutes
Secondary 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period . 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period. at 1, 3, 6, 12, 24, 36 and 48 hours
Secondary 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 amsay Sedation Scale (RSS) The RSS is a user-friendly and therefore commonly used sedation scale, with scores ranging from +4 (a violent dangerous patient) to -5 (an unarousable patient).6 A sedation score of 0 is most often therapeutically targeted, as it correlates with an alert and calm patient. at 1, 3, 6, 12, 24, 36 and 48 hours
Secondary Intraoperative hemodynamic parameters blood pressure blood pressure measurement obtained by non-invasive blood pressure cuff during intraoperative and postoperative in PACU expressed in mmhg at 1, 3, 6, hours
Secondary Minimum alveolar concentration (MAC) requirements Minimum alveolar concentration or MAC is the concentration, often expressed as a percentage by volume, of a vapour in the alveoli of the lungs that is needed to prevent movement (motor response) in 50% of subjects in response to surgical (pain) stimulus. during intraoperative periods expressed in minutes
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