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Enrolling by Invitation

NCT Number: NCT05705128

Dexmedetomidine in Postoperative Analgesia

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut University Hospital

Asyut, 71516, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine will be given with bupivaciane for postoperative pain control

Primary outcomes

  1. numerical rating pain scale

    Time frame: 24 hours

    graded from 0 to 10 (0 = no pain, 10 = the worst possible pain)

Secondary outcomes

  1. complications

    Time frame: 24 hours

    postoperative complications

Sponsors and collaborators

Lead sponsor

New Valley University

Other

Registry information

Official study title

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

Acronym: Any

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 30, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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