Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Intranasal Dexmedetomidine; Intranasal Bupivacaine; Septoplasty Surgeries

Treatments: Drug: Bupivacaine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03926663

FMBSUREC/05032019/Moselhy

Details and patient eligibility

About

Pain is particularly common after nasal surgery, especially when bone manipulation and periosteal irritation are involved. Appropriate pain control is an important consideration in the post-surgical management of patients.

Full description

Multiple researches and clinical observations suggest that pain reduction can be achieved in nasal surgery by using local anesthesia.The combination of local anesthetic infiltration, directly in the surgical field, with general anesthesia provides beneficial analgesic effects by blocking nociceptive pathways, and there by it reduces the need for systemic analgesics.

The use of α-2 Adrenergic receptor (adrenoceptor) agonists in anesthesia were the focus of interest for their sedative, analgesic, and perioperative sympatholytic and cardiovascular stabilizing effects with reduced anesthetic requirements. α-2 agonists, inhibit substance P release in the nociceptive pathway at the level of the dorsal root neuron; in addition, α-2 adrenergic receptors located at nerve endings may have a role in the analgesic effect of the drug by preventing norepinephrine release.

In this study, the combined effects of dexmedetomidine with bupivacaine as local anesthetics vs bupivacaine, will be investigated in septoplasty to determine the need for rescue drugs as propanlol and nitroglycerine, as hypotensive agents,for bloodless surgical field and optimal procedure for pain control

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged from 18- 60 years
• ASA physical status I
• Undergoing septoplasty

Exclusion criteria

• Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension.
• History of renal or hepatic insufficiency
• Endocrinal Diseases

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

group Bupivacaine

Experimental group

Description:

Group B; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) as preincisional local infiltration of the nasal mucosa of the nasal septum ,injected once before surgical intervention

Treatment:

Drug: Bupivacaine

group Bupivacaine +Dexmedetomidine

Active Comparator group

Description:

group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention.

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine