The Effect of Dexamethasone on Rebound Pain in Patients Receiving Ilioinguinal and Iliohypogastric Nerve Block

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

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Drug: Dexamethasone; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammet Korkusuz, M.D.; Phone Number: 338 226 33 20; Email: drmuhammetkorkusuz@gmail.com
• Study Contact Backup: Name: Betul Basaran, MD; Phone Number: 338 226 33 20; Email: betulbasaran1@yahoo.com

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Taining and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Dexa; After induction of general anesthesia, an ultrasound-guided block of the ilioinguinal and iliohypogastric nerve block will be performed using 20 ml 0.5% bupivacaine. 5 mg dexamethasone in a 50 ml syringe containing normal saline will be infused within 15 minutes. A multimodal analgesia regimen will be applied postoperatively. The syringe will be prepared by a nurse outside the research team and the study participants, care providers, and data collectors will be blinded to the allocation throughout the study	Drug: Dexamethasone; 5 mg dexamethasone in a 50 ml syringe containing normal saline will be infused within 15 minutes. The syringe will be prepared by a nurse outside the research team and the Study participants, care providers, and data collectors will be blinded to the allocation throughout the study. Global Quality of Recovery- 15 score and standard pain follow-up scores will be noted.; Other Names: Standard Pain Follow up; Global Quality of Recovery-15 score
Sham Comparator: Group S; After induction of general anesthesia, an ultrasound-guided block of the ilioinguinal and iliohypogastric nerve block will be performed using 20 ml 0.5% bupivacaine. 50 mL normal saline in a 50 ml syringe will be infused within 15 minutes. A multimodal analgesia regimen will be applied postoperatively. The syringe will be prepared by a nurse outside the research team and the study participants, care providers, and data collectors will be blinded to the allocation throughout the study	Drug: Saline; A 50 ml syringe containing normal saline will be infused within 15 minutes. The syringe will be prepared by a nurse outside the research team and the study participants, care providers, and data collectors will be blinded to the allocation throughout the study. Global Quality of Recovery- 15 score and standard pain follow-up scores will be noted.; Other Names: Global Quality of Recovery-15 score; Standard Pain Follow up and Monitorization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rebound Pain Score	Modified Rebound Pain score is described as the difference between the last recorded postanesthesia care pain score while it will be working and the highest pain score reported within the first 24 h after IIN/IHN blocks will be performed. Pain score will be calculated with Numeric Rating Scale (NRS)(0 = no pain; 10 = worst pain imaginable)	Postoperative 24 hours
Analgesic consumption	Postoperative total opioid consumption	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale scores at rest and mobilization	Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.	Postoperative 48 hours
Quality of Recovery 15 Score	Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.	Postoperative Day 1
Quality of Sleep	Patient's perceived sleep quality will be assessed with Likert scale.Likert scale is scored from 1(very dissatisfied) to 5 (very satisfied).	One week after surgery
Analgesic consumption	Postoperative total opioid consumption	Postoperative 48 hours
Adverse events	Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.	Postoperative 24 hour
Glucose measurement	Glucose measurement	Postoperative 24th hour
Surgical infection	Surgical infection	Postoperative 14 days

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Muhammet Korkusuz, MD, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Dexamethasone; Bupivacaine; Ilioinguinal and Iliohypogastric nerve block; Rebound Pain
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 08-2021/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No