Opioid Sparing Effect of Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: a Randomized Controlled Clinical Trial.

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Sinus Surgery

Treatments: Drug: Magnesium Sulphate 500 mg; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06752525

SPGB sinus surgery

Details and patient eligibility

About

Functional endoscopic sinus surgery (FESS) is widely recognized as a safe and preferred treatment option for various conditions, particularly nasal polyps and rhinosinusitis . This technique has been shown to improve postoperative symptoms by 86.3% in patients with chronic inflammatory paranasal sinus diseases .

The aim of this study is to evaluate the effect of adding of MgSO4 to bupivacaine via SPGB block for postoperative pain for 24 hours in patients scheduled for FESS as opioid free anaesthesia.

Full description

However, managing postoperative pain remains a significant challenge. Research suggests that 86% of surgical patients experience pain, with 75% enduring moderate to severe levels .

The Sphenopalatine Ganglion Block (SPGB) is an effective, safe, and well-tolerated method for managing craniofacial pain. The ganglion comprises both sensory and autonomic nerves, which innervate the nasal cavity, palate, and certain areas of the nasopharynx and oropharynx . SPGB involves the administration of analgesic agents into the nasal cavity, typically through an endoscopic approach due to the challenges of transnasal injection . Some complications, such as postoperative nosebleeds, and temporary numbness of the palate, have been observed following the blockade with endoscopic intervention, but these are generally temporary .

Studies evaluating the effects of the sphenopalatine block in endoscopic sinus surgery suggest that patients who received the ganglion block experienced reduced postoperative pain compared to those in the placebo group when combined with general anaesthesia .

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patients programmed for elective FESS

  • American society of anaesthesiologists (ASA) physical state I-II
  • Age over 18 years and less than 60-years-old.

Exclusion criteria

• • Known hypersensitivity to the study drugs.

  • Inability to accurately describe postoperative pain to investigators.
  • Opioid tolerance or dependence.
  • Patient refusal
  • History of renal, liver, cardiac, neuropsychiatric disorder problems.
  • Bleeding or coagulation abnormality.
  • Infection at the site of injection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Group A

Experimental group

Description:

patients will receive SPGB block with 2 ml volume on each side (1.5 mL of bupivacaine 0.5% + 0.5 mL of magnesium sulphate 10%)

Treatment:

Drug: Bupivacaine

Drug: Magnesium Sulphate 500 mg

group B

Experimental group

Description:

patients will receive SPGB block with 2 ml volume on each side (1.5 ml bupivacaine 0.5% plus 0.5 ml saline).

Treatment:

Drug: Bupivacaine