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Clinical trial

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

ID
Name
08-2021/11
Description
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.
Trial arms
Trial start
2022-01-06
Estimated PCD
2023-04-15
Trial end
2023-05-15
Status
Completed
Treatment
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.
Arms:
Group Dexa
Other names:
Global Quality of Recovery-15 score, Standard Pain Follow up
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.
Arms:
Group S
Other names:
Global Quality of Recovery-15 score, Standard Pain Follow up and Monitorization
Size
60
Primary endpoint
Modified Rebound Pain Score
Postoperative 24 hours
Analgesic consumption
Postoperative 24 hours
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-05-16

1 organization

1 product

1 drug

1 indication

Organization
Karaman Training and Research Hospital
Product
Dexamethasone
Indication
Inguinal Hernia
Drug
Varlilumab