Dexmedetomidine in Postoperative Analgesia (Any)

Comparison Between Effect of Addition of Dexamethasone and Dexmedetomidine in Combination With Bupivacaine for Pain Relief After Shoulder Arthroscopic Surgeries

There is a high incidence reaching up to 45%; of severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery, which is often significant enough to interfere with initial recovery and rehabilitation.Various peripheral nerve blocks have been used to reduce intraoperative anesthetic requirements to improve rapid recovery and reduce postoperative pain.

Study Overview

• Status: Recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to ISB.most of the nerve supply from C5 and C6 nerve roots are carried by suprascapular and the axillary nerves. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder.

Dexamethasone is a glucocorticoid that is commonly used to decrease the body's inflammatory response. Doses of 1, 2, 4, and 8 mg have been used as an adjuvant in interscalene, supraclavicular, ankle, and brachial plexus blocks . However, when dexamethasone is used as an adjuvant in a PNB, the specific mechanism of action is unknown . Dexamethasone may produce extended analgesia through vasoconstriction and reduced absorption of local anesthetic or through "direct action on the nerve cell to reduce neural discharge" .

Despite having an unknown mechanism, a Cochrane review of 35 trials of 2702 participants determined that perineural dexamethasone adjuvant increased sensory block 6.7 hours (95% confidence interval) in comparison to a placebo . Similarly, intravenous dexamethasone increased sensory block 6.2 hours in comparison Dexmedetomidine is a highly selective and potent central alpha-2 adrenergic receptor agonist. Administration of this adjuvant in miscellaneous methods has received considerable attention in recent years. Due to its analgesic and sedative effects, besides the lack of any respiratory-sparing effects, administration of this adjuvant has been effective in reducing the need for opioids in the perioperative period and may even result in cooperative sedation . Given the sympatholytic effects of dexmedetomidine (hypotension and bradycardia), in addition to oversedation, especially when administered intravenously or at high doses, caution must be taken in administering this drug, especially in elderly patients.

The neuraxial administration of dexmedetomidine has nociceptive effects on somatic and visceral pains . It also reduces postoperative pain and prolongs analgesia, although there is a risk of bradycardia. Various doses of dexmedetomidine, along with a number of analgesic drugs, have been used in many studies. However, the exact dose of dexmedetomidine, as an adjuvant drug administered along with other intravenous drugs in the perioperative period, has been controversial.

The proposed mechanism for perineural dexmedetomidine in PNBs as first studied in rat models is similar to that of clonidine, which relies not on alpha-2 agonism mechanism, but instead blocks hyperpolarization-activated Ih cation currents and causes vasoconstriction for prolonged analgesia . Perineural dexmedetomidine adjunct use is off-label, and proper risk-benefit analysis, especially in patients where bradycardia and hypotension would be concerning, would be necessary before even more widespread use of dexmedetomidine in PNBs can be expected .

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Alaa m Atia, professor; Phone Number: (088) 2411900 - 2080278; Email: alaaguhina@yahoo.com
• Study Contact Backup: Name: wesam n mohammed, assistant professor; Phone Number: (088) 2411900 - 2080278; Email: dr.wesamnashat2015@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71516
    • Recruiting
    • Assiut University Hospital
    • Contact: Alas Attia, Professor; Phone Number: 01099923117; Email: alasguhina@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing elective shoulder arthroscopy under general anesthesia

Exclusion Criteria:

• Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
• Altered conscious level.
• Pregnancy. .Body mass index (BMI > 35).
• Patients who have difficulty understanding the study protocol
• Patients who have any known contraindication to study medications
• Patient refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexamethasone group; patients will receive dexamethasone with bupivacaine before general anaesthesia	Drug: Dexmedetomidine; Dexmedetomidine will be given with bupivaciane for postoperative pain control
Active Comparator: dexmedetomidine group; patients will receive dexemedetomidine with bupivacaine before general anaesthesia	Drug: Dexmedetomidine; Dexmedetomidine will be given with bupivaciane for postoperative pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating pain scale	graded from 0 to 10 (0 = no pain, 10 = the worst possible pain)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	postoperative complications	24 hours

Collaborators and Investigators

• Sponsor: New Valley University
• Investigators: Principal Investigator: ahmed abdelsabour, lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: Assiut anesthesia g35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No