An interventional study of Dexamethasone and Saline in Inguinal Hernia, sponsored by Karaman Training and Research Hospital. Completed at 1 site in Turkey. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Karaman Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 739 interventional studies indexed under Hernia.
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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
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
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
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
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)
Time frame: Postoperative 24 hours
Analgesic consumption
Postoperative total opioid consumption
Time frame: Postoperative 24 hours
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.
Time frame: Postoperative 48 hours
Quality of Recovery 15 Score
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.
Time frame: Postoperative Day 1
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).
Time frame: One week after surgery
Analgesic consumption
Postoperative total opioid consumption
Time frame: Postoperative 48 hours
Adverse events
Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Time frame: Postoperative 24 hour
Glucose measurement
Glucose measurement
Time frame: Postoperative 24th hour
Surgical infection
Surgical infection
Time frame: Postoperative 14 days
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Karaman Training and Research Hospital