Dexmedetomidine in Postoperative Analgesia

NCT ID: NCT05705128

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-05-20

Brief Summary

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.

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 .

Conditions

Pain Management

Study Design

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

Study Groups

dexamethasone group

patients will receive dexamethasone with bupivacaine before general anaesthesia

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine will be given with bupivaciane for postoperative pain control

dexmedetomidine group

patients will receive dexemedetomidine with bupivacaine before general anaesthesia

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine will be given with bupivaciane for postoperative pain control

Interventions

Dexmedetomidine

Dexmedetomidine will be given with bupivaciane for postoperative pain control

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Valley University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ismail Abdelsabour

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed abdelsabour, lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Assiut anesthesia g35

Identifier Type: -

Identifier Source: org_study_id