Clinical trial NCT05172908: The Effect of Dexamethasone on Rebound Pain in Patients Receiving Ilioinguinal and Iliohypogastric Nerve Block
Official title: The Effect of Preoperative Intravenous Dexamethasone on Postoperative Rebound Pain and Sleep Quality in Patients Receiving Ultrasonography-Guided Ilioinguinal and Iliohypogastric Nerve Block for Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Dexamethasone
Ilioinguinal and Iliohypogastric nerve block
Bupivacaine
Rebound Pain
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rebound pain is a newly defined phenomenon, observed within the first 24 hours after the operation. Open inguinal hernia repair is a common surgical procedure that can be associated with pain of the either acute or chronic character. A peripheral nerve block of the ilioinguinal (IIN) and iliohypogastric (IHN) nerves is a relatively well-known method for postoperative pain management. However, rebound pain after IIN/IHN block resolution may reduce its overall benefit. The primary aim is to assess whether intravenous dexamethasone reduces postoperative opioid consumption and the incidence of rebound pain in patients undergoing unilateral hernia repair in adults.

Detailed description: Male patients older than 18 years, of American Society of Anesthesiologists physical status I or II, and scheduled for unilateral primary hernia repair with a Lichtenstein style (open surgery with insertion of mesh) under general anesthesia will be included in the study. The patients will be randomized using a computer-generated randomization technique. After induction of general anesthesia, the patients in the dexamethasone group (Group Dex) will receive 5 mg dexamethasone in a 50 ml syringe containing normal saline. The patients in the saline group (Group S) will receive normal saline in a 50 ml syringe. Ultrasound-guided block of the ilioinguinal (IIN) and iliohypogastric (IHN) nerves will be performed on all patients included in both groups. The primary aim is to assess whether intravenous dexamethasone reduces postoperative opioid consumption and the incidence of rebound pain in patients undergoing unilateral hernia repair in adults.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Having signed a written informed consent form
* Scheduled for unilateral primary hernia repair Lichtenstein style (open surgery with insertion of mesh) under general anesthesia

Exclusion Criteria:

* Chronic opioid use (more than one month of 60 mg of oral morphine equivalents daily)
* Contraindications to peripheral nerve blocks including localized infection, coagulopathy, or allergy to local anesthetics
* Stomach ulcer
* Severe obesity (body mass index \> 35 kg/m2)
* Uncontrolled Diabetes
* Psychiatric disorders
* Systemic steroid use
* Neuropathic disorder
* Can not communicate in Turkish

Primary outcomes:
measure: Modified Rebound Pain Score
timeFrame: Postoperative 24 hours
measure: Analgesic consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Numerical Rating Scale scores at rest and mobilization
timeFrame: Postoperative 48 hours
measure: Quality of Recovery 15 Score
timeFrame: Postoperative Day 1
measure: Quality of Sleep
timeFrame: One week after surgery
measure: Analgesic consumption
timeFrame: Postoperative 48 hours
measure: Adverse events
timeFrame: Postoperative 24 hour
measure: Glucose measurement
timeFrame: Postoperative 24th hour
measure: Surgical infection
timeFrame: Postoperative 14 days
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Taining and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Muhammet Korkusuz, MD
role: PRINCIPAL_INVESTIGATOR
References: