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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
Karaman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Dexamethasone, Ilioinguinal and Iliohypogastric nerve block, Bupivacaine, Rebound Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Karaman Taining and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group Dexa

Group S

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
Analgesic consumption
Postoperative total opioid consumption

Secondary Outcome Measures

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.
Quality of Recovery 15 Score
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.
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).
Analgesic consumption
Postoperative total opioid consumption
Adverse events
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Glucose measurement
Glucose measurement
Surgical infection
Surgical infection

Full Information

First Posted
December 10, 2021
Last Updated
May 15, 2023
Sponsor
Karaman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05172908
Brief Title
The Effect of Dexamethasone on Rebound Pain in Patients Receiving Ilioinguinal and Iliohypogastric Nerve Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Dexamethasone, Ilioinguinal and Iliohypogastric nerve block, Bupivacaine, Rebound Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Dexa
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group S
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Global Quality of Recovery-15 score, Standard Pain Follow up
Intervention Description
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
Intervention Name(s)
Saline
Other Intervention Name(s)
Global Quality of Recovery-15 score, Standard Pain Follow up and Monitorization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Rebound Pain Score
Description
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)
Time Frame
Postoperative 24 hours
Title
Analgesic consumption
Description
Postoperative total opioid consumption
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Numerical Rating Scale scores at rest and mobilization
Description
Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.
Time Frame
Postoperative 48 hours
Title
Quality of Recovery 15 Score
Description
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.
Time Frame
Postoperative Day 1
Title
Quality of Sleep
Description
Patient's perceived sleep quality will be assessed with Likert scale.Likert scale is scored from 1(very dissatisfied) to 5 (very satisfied).
Time Frame
One week after surgery
Title
Analgesic consumption
Description
Postoperative total opioid consumption
Time Frame
Postoperative 48 hours
Title
Adverse events
Description
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Time Frame
Postoperative 24 hour
Title
Glucose measurement
Description
Glucose measurement
Time Frame
Postoperative 24th hour
Title
Surgical infection
Description
Surgical infection
Time Frame
Postoperative 14 days

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammet Korkusuz, MD
Organizational Affiliation
Karaman Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karaman Taining and Research Hospital
City
Karaman
ZIP/Postal Code
70200
Country
Turkey

12. IPD Sharing Statement

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