Clinical trial NCT06174675: The Effect of Combined Bilateral Infraorbital and Infratrochlear Nerve Block in Nasal Surgeries
Official title: Combined Bilateral Infraorbital and Infratrochlear Nerve Block Versus Conventional Systemic Analgesia for Patients Undergoing Nasal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Perioperative pain management is one of the most important issues of most surgical procedures. The goal of every pain management technique is to reduce or eliminate pain and discomfort with minimum side effects (Garmella and Cellini, 2012).

Nasal surgical procedures are associated with a high incidence of emergence agitation leading to severe complications such as bleeding and delayed recovery which increase the hospital stay (Kim et al., 2015).

Although the cause of emergence agitation is not well established, Pain in the immediate post-operative period is one of the significant risk factors for emergence agitation. Multiple analgesic interventions are applied to the patient before, during and after surgery prevent these complications (Gray et al., 2018).

The most utilized analgesic interventions are combinations of narcotic and non-steroidal anti-inflammatory drugs. However, they are associated with gastrointestinal and neurological side effects which cause discomfort to the patient and affect surgical recovery profile (Çelik et al., 2018). Therefore, the utility of combining regional nerve block with general anesthesia has been popularized in clinical practice to provide improved perioperative analgesia, decreased narcotic consumption and enhanced emergence and recovery characteristics (Mariano et al., 2009; Ibrahim et al., 2018).

The infraorbital nerve (ION) is a branch of the maxillary part of the trigeminal nerve. This nerve innervates the skin of the nose and septum mobile nasi. The infratrochlear nerve (ITN) innervates the root of the nose and is an extraconal branch of the nasociliary nerve, which is a branch of the ophthalmic portion of the trigeminal nerve (Choi et al., 2019).

Although these nerve blocks are simple and easy to use with few complications, there are limited reports that suggest combined bilateral infraorbital and infratrochlear nerve blocks to be effective to facilitate pain management and reduce anesthetic agent consumption and perioperative dose of narcotics in nasal procedures (Cekic et al., 2013; Boselli et al., 2016).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Total amount of intraoperative fentanyl
timeFrame: throughout the surgery
Secondary outcomes:
measure: 1. Hemodynamic changes
timeFrame: every 15 minutes during the surgery, upon arrival to the PACU and after 30 min.
measure: The time from induction of anesthesia to the first additional dose of fentanyl intraoperative.
timeFrame: throughout the surgery
measure: Total amount of postoperative pethidine given
timeFrame: 24 hours postoperatively
measure: Number of patients needed rescue analgesia intraoperative or postoperative.
timeFrame: throughout the surgery and 24 hours postoperatively
measure: 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.
timeFrame: 24 hours postoperatively
measure: Postoperative side effects such as nausea, vomiting and headache.
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospitals
Study officials:
affiliation: faculty of medicine, Ain Shams University
name: Ayat Elshaer, ass.lecturer
role: PRINCIPAL_INVESTIGATOR
References: