Lidocaine Versus Bupivacaine for Sphenopalatine Ganglion Block

NCT05269147 | Completed DMC

• 1 other identifier: 506/1/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septum; Deviation, Congenital

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain-free duration (minutes)

  this time will be recorded from the time of extubation to the first postoperative analgesic request when VAS ≥ 4

  24 hours

Secondary Outcomes (2)

• Postoperative Visual Analog Pain Score

  24 hours

• Surgical field assessment from incision to closure

  3 hours

Study Arms (3)

SBGB with normal saline

PLACEBO COMPARATOR

patients will receive standardized general anesthesia + SBGB with normal saline.

Procedure: Sphenopalatine Ganglion Block (SPGB)

SBGB with lidocaine 2%

ACTIVE COMPARATOR

patients will receive standardized general anesthesia + SBGB with lidocaine 2%

Procedure: Sphenopalatine Ganglion Block (SPGB)

SBGB with bupivacaine 0.5%

ACTIVE COMPARATOR

patients will receive standardized general anesthesia+ SBGB with bupivacaine 0.5%

Procedure: Sphenopalatine Ganglion Block (SPGB)

Interventions

Sphenopalatine Ganglion Block (SPGB) PROCEDURE

The SPGB will be done after the patient is generally anesthetized and will be performed by the operating surgeon using a transnasal endoscopic approach through the posterior and over the middle turbinate tail in the pterygopalatine fossa. The patient will be placed in the supine position with head extension. The prepared solution (4 ccs 2% lidocaine or 0.5% bupivacaine or normal saline and 1 cc 8 mg dexamethasone) will be given (2,5 cc) to each side of the nose. The surgery was started 10 minutes after the application of SPBG to allow sufficient time for the block to develop.

SBGB with bupivacaine 0.5%; SBGB with lidocaine 2%; SBGB with normal saline

Eligibility Criteria

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

You may qualify if:

• The patients planned to perform endoscopic septoplasty
• American Society of Anesthesiologists class I and II

You may not qualify if:

• patients that will be received additional surgery with endoscopic septoplasty
• patients under the age of 18
• Patients have systemic or bleeding disorders
• patients who disincline to participate in the study

Sponsors & Collaborators

• Huda Fahmy Mahmoud, PhD: lead

Study Sites (1)

Huda Fahmy

Aswān, 81511, Egypt

Location

MeSH Terms

Interventions

Sphenopalatine Ganglion Block

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• huda F fahmy

  Aswan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of Anaesthesia and Intensive Care department

Model Details: To determine the efficacy of lidocaine versus bupivacaine for sphenopalatine ganglion block in patients undergoing endoscopic septoplasty. Postoperative Pain-free duration (minutes) will be recorded from the time of extubation to the first postoperative analgesic request when VAS ≥ 4 is the primary outcome.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

EG (1)