The Effect of Combined Bilateral Infraorbital and Infratrochlear Nerve Block in Nasal Surgeries

NCT06174675 | Completed

• 1 other identifier: FMASU MD136/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the efficacy of adding a pre-emptive combined bilateral infraorbital and infratrochlear nerve blocks with bupivacaine 0.25% in decreasing intraoperative and postoperative analgesics consumption and maintaining intraoperative hemodynamic stability during nasal surgeries.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Total amount of intraoperative fentanyl

  throughout the surgery

Secondary Outcomes (6)

• 1. Hemodynamic changes

  every 15 minutes during the surgery, upon arrival to the PACU and after 30 min.

• The time from induction of anesthesia to the first additional dose of fentanyl intraoperative.

  throughout the surgery

• Total amount of postoperative pethidine given

  24 hours postoperatively

• Number of patients needed rescue analgesia intraoperative or postoperative.

  throughout the surgery and 24 hours postoperatively

• Any complications related to the nerve block such as injection site pain, edema, hematoma or neurological deficits in the blocked area such as paresthesia or prolonged paralysis of the upper lip.

  24 hours postoperatively

Study Arms (2)

Study group

ACTIVE COMPARATOR

patients will receive combined bilateral infraorbital and infratrochlear nerve block. 20 patients

Procedure: combined bilateral infraorbital and infratrochlear nerve blocks

control group

NO INTERVENTION

patients will not receive the block and will receive intravenous analgesia according to standard protocol. 20 patients.

Interventions

combined bilateral infraorbital and infratrochlear nerve blocks PROCEDURE

Filling the block labelled syringe with 8 mL of bupivacaine 0.25%. Starting with Infraorbital nerve block using an extraoral approach.Inserting a 25-gauge needle laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. Positioning of the index finger of the non-dominant hand above the infraorbital foramen and advancing the needle feeling it beneath the finger to avoid globe penetration injury. Injecting 3 mL of the study solution slowly after confirming negative aspiration of blood and taking care not to inject into the foramen itself. Shifting to infratrochlear nerve block by inserting the needle 1 cm above the inner canthus targeting the junction of the orbit and the nasal bone. Injecting 1mL of the study solution after confirming negative aspiration of blood. Performing contralateral nerve block in the same manner. Applying pressure to four injection points for one minute to prevent hematoma.

Study group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group: 18 - 55 years old.
• American Society of Anesthesiologists (ASA) Physical Status Class I or II
• Scheduled for elective nasal surgery under general anesthesia.

You may not qualify if:

• Refusing to participate in the study or inability to provide informed consent.
• History of allergy to the medications used in the study.
• Contraindications to regional anesthesia (including coagulopathy, INR ≥ 1.4 and local infection).
• Compromised renal or liver functions.
• History of substance or alcohol abuse.
• Pre-existing chronic pain of different etiology.
• Psychiatric disorders.
• Pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, Cairo Governorate, 002, Egypt

Location

Study Officials

• Ayat Elshaer, ass.lecturer

  faculty of medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)