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

NCT06752525 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: SPGB sinus surgery
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sinus Surgery

Keywords

sphenopalatine ganglion block

Outcome Measures

Primary Outcomes (1)

• postoperative pain according to (NRS)

  The effect of adding of MgSO4 to bupivacaine via SPGB block for postoperative pain according to (NRS) for 24 hours in patients scheduled for FESS

  24 hours

Study Arms (2)

Group A

EXPERIMENTAL

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%)

Drug: Bupivacaine; Drug: Magnesium Sulphate 500 mg

group B

EXPERIMENTAL

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

Drug: Bupivacaine

Interventions

Bupivacaine 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%).

Group A; group B

Magnesium Sulphate 500 mg 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 A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15.

  PMID: 26370724 BACKGROUND

• Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.

  PMID: 21739090 BACKGROUND

• Cho DY, Drover DR, Nekhendzy V, Butwick AJ, Collins J, Hwang PH. The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):212-8. doi: 10.1002/alr.20040. Epub 2011 Apr 13.

  PMID: 22287376 BACKGROUND

• Sanders M, Zuurmond WW. Efficacy of sphenopalatine ganglion blockade in 66 patients suffering from cluster headache: a 12- to 70-month follow-up evaluation. J Neurosurg. 1997 Dec;87(6):876-80. doi: 10.3171/jns.1997.87.6.0876.

  PMID: 9384398 BACKGROUND

• Xiong BJ, Xu Y, Jin GL, Liu M, Yang J, Yu CX. Analgesic effects and pharmacologic mechanisms of the Gelsemium alkaloid koumine on a rat model of postoperative pain. Sci Rep. 2017 Oct 27;7(1):14269. doi: 10.1038/s41598-017-14714-0.

  PMID: 29079733 BACKGROUND

• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

  PMID: 24237004 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Ahmed Mohamed Ali Ismaeil, resident doctor

CONTACT

+20106 9071633; Ahmed.16285222@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12