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Completed

NCT Number: NCT05172908

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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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: Global Quality of Recovery-15 score, Standard Pain Follow up

Saline

Drug

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

Primary outcomes

  1. Modified Rebound Pain Score

    Time frame: Postoperative 24 hours

    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)

  2. Analgesic consumption

    Time frame: Postoperative 24 hours

    Postoperative total opioid consumption

Secondary outcomes

  1. Numerical Rating Scale scores at rest and mobilization

    Time frame: Postoperative 48 hours

    Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.

  2. Quality of Recovery 15 Score

    Time frame: Postoperative Day 1

    Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.

  3. Quality of Sleep

    Time frame: One week after surgery

    Patient's perceived sleep quality will be assessed with Likert scale.Likert scale is scored from 1(very dissatisfied) to 5 (very satisfied).

  4. Analgesic consumption

    Time frame: Postoperative 48 hours

    Postoperative total opioid consumption

  5. Adverse events

    Time frame: Postoperative 24 hour

    Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.

  6. Glucose measurement

    Time frame: Postoperative 24th hour

    Glucose measurement

  7. Surgical infection

    Time frame: Postoperative 14 days

    Surgical infection

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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