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

K

Karaman Training and Research Hospital

Status

Completed

Conditions

Inguinal Hernia

Treatments

Drug: Saline
Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT05172908
08-2021/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Group Dexa
Active Comparator group
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
Treatment:
Drug: Dexamethasone
Group S
Sham Comparator group
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
Treatment:
Drug: Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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