NCT05269147

Lidocaine Versus Bupivacaine for Sphenopalatine Ganglion Block

Completed NA Last updated 7 September 2022

What this trial tests

NA trial testing Sphenopalatine Ganglion Block (SPGB) in Septum; Deviation, Congenital in 60 participants. Completed in 1 September 2022.

Timeline

1 March 2022

Primary endpoint
1 September 2022

1 September 2022

Quick facts

Lead sponsor	Huda Fahmy Mahmoud, PhD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2022
Primary completion	1 September 2022
Estimated completion	1 September 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Sphenopalatine Ganglion Block (SPGB)

Conditions studied

• Septum; Deviation, Congenital — all drugs for Septum; Deviation, Congenital →

Sponsor

Huda Fahmy Mahmoud, PhD — full company profile →

Who can join

Adults 18 to 60, any sex, with Septum; Deviation, Congenital. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The endoscopic septoplasty technique is one of the most frequently performed operations by otolaryngologists throughout the world. It is suggested that 86% of patients who undergo an endoscopic septoplasty would experience pain, and 75% of them suffer moderate to extreme levels of pain. Appropriate management of post-operative pain is a critical component of nasal surgery as it reduces perioperative morbidity, complications, hospital stay, and costs.

The sphenopalatine ganglion (SPG) is located in the cranial section of the autonomous nervous system; it is connected with the brain stem and the central nervous system (CNS) and bears unique characteristics favorable for the treatment of many painful syndromes involving the face and head. Sphenopalatine ganglion block (SPGB), along with general anesthesia (GA), is one of the regional anesthetic techniques used to reduce the need for systemic analgesia and provides relative hypotension with controlled heart rate that may lead to a better surgical field for endoscopic surgery. In addition, SPGB appears to shorten hospital stays and reduce narcotic requirements in the recovery area. SPGB with bupivacaine delivered repetitively appears to decreased postoperative pain and more satisfaction with the surgery for patients. Also, Bupivacaine usage in nasal surgery provides better analgesia at least in the first 8 hours period and does not cause more bleeding. On the other hand, SPGB with lidocaine was found to decrease the need for additional analgesics in the postoperative period, increase patient satisfaction, decrease the length of hospital stay, and as a consequence, reduce the rate of secondary infections. However, no previous studies have demonstrated the superiority of one drug over the other when performing an intranasal SPG block.

Aim of the work: To determine the efficacy of lidocaine versus bupivacaine for sphenopalatine ganglion block in patients undergoing endoscopic septoplasty.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.