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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172908
• Other study ID #: 08-2021/11
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: December 2022
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Karaman Taining and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Analgesic consumption	Postoperative total opioid consumption	Postoperative 24 hours
Secondary	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
Secondary	Quality of Recovery 15 Score	Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.	Postoperative Day 1
Secondary	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
Secondary	Analgesic consumption	Postoperative total opioid consumption	Postoperative 48 hours
Secondary	Adverse events	Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.	Postoperative 24 hour
Secondary	Glucose measurement	Glucose measurement	Postoperative 24th hour
Secondary	Surgical infection	Surgical infection	Postoperative 14 days