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

NCT05172908 | Completed

• 1 other identifier: 08-2021/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Dexamethasone; Ilioinguinal and Iliohypogastric nerve block; Bupivacaine; Rebound Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Numerical Rating Scale scores at rest and mobilization

  Postoperative 48 hours

• Quality of Recovery 15 Score

  Postoperative Day 1

• Quality of Sleep

  One week after surgery

• Analgesic consumption

  Postoperative 48 hours

• Adverse events

  Postoperative 24 hour

Study Arms (2)

Group Dexa

ACTIVE COMPARATOR

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

Group S

SHAM COMPARATOR

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

Interventions

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.

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

Group Dexa

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.

Also known as: Global Quality of Recovery-15 score, Standard Pain Follow up and Monitorization

Group S

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Related Publications (1)

• Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Kurucay Y. The effects of dexamethasone added to ilioinguinal/iliohypogastric nerve (IIN/IHN) block on rebound pain in inguinal hernia surgery: a randomized controlled trial. Hernia. 2023 Dec;27(6):1571-1580. doi: 10.1007/s10029-023-02841-9. Epub 2023 Jul 21.

  PMID: 37477788 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Muhammet Korkusuz, MD

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 29, 2021
• Study Start: January 6, 2022
• Primary Completion: April 15, 2023
• Study Completion: May 15, 2023
• Last Updated: May 16, 2023

Record last verified: 2022-12

Locations

TU (1)