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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2023-05-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type 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.

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

Group Type SHAM_COMPARATOR

Saline

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Global Quality of Recovery-15 score Standard Pain Follow up Global Quality of Recovery-15 score Standard Pain Follow up and Monitorization

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No