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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Sinus Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

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%)

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

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%).

Magnesium Sulphate 500 mg

Intervention Type DRUG

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

group B

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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

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%).

Interventions

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Bupivacaine

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%).

Intervention Type DRUG

Magnesium Sulphate 500 mg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No