Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block

Pain, Postoperative Clinical Trial

Official title:

Efficacy of Dexmedetomidine as an Adjuvant to Quadratus Lumborum Block for Paediatric Groin Surgery:A Randomized Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05979376
• Other study ID #: E-83045809-604.01.01-631721
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective double blinded study will be conducted over 60 pediatric patients ASA (American Association of Anesthesiologists) I and II between the age of 1-7 years old, who will be scheduled for unilateral groin surgery. Patients will be randomly allocated into 3 study groups: Control group that only received local anesthetics ( bupivacaine) Group II bupivacaine with the dexmetedomidine ( 0,5mcg/kg ) and group III bupivacaine with the dexmedetomidine (1mcg/kg).Patients in all groups will receive quadratus lumborum block.

Bradycardia, hypotension, atropine, and bolus fluid infusion requirements will be recorded. When there was up to a 30% decrease in basal mean blood pressure, a crystalloid infusion bolus will be given at 10 ml/kg. When bradycardia occurred , atropine will be given at a dose of 0.02 mg/kg. Patients will be followed up in the postoperative recovery unit for the first 2 hours, and then in the ward. The RAMSEY sedation scale and WATCHA agitation scale were evaluated at 5, 15, 30, and 60 minutes in the postoperative recovery unit. Nausea, vomiting, and other side effects were recorded if present.

Time to first analgesic requirement ( primary outcome) , FLACC Scale scores will be recorded within 24h postoperatively, total dose of analgesic consumption, incidence of postoperative complications as hypotension, bradycardia, vomiting, pruritis and respiratory depression will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

The study included children aged 1-7 years with ASA (American Society of Anesthesiologists) I-II, who underwent elective, unilateral, groin surgery (inguinal hernia, orchiopexy, hydrocele) with the consent of their families

Exclusion Criteria:

• Children who were aged outside the range of 1-7 years, with ASA III or higher, allergic to local anesthetics, had an infection in the injection area, had contraindications for regional anesthesia such as coagulopathy, whose families did not give consent, were undergoing laparoscopic orchidopexy, undergoing bilateral surgery, had a body mass index of >30 kg/m2, and were expected to be admitted to the intensive care unit during the postoperative period were excluded from the study

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
Turkey	PINAR Kendigelen	Istanbul	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to first rescue analgesic requirement	the time to first rescue analgesic requirement within the first 24 postoperative hours,	24 hours
Secondary	postoperative pain scores FLACC (face, legs, activity, cry, and consolability)	postoperative pain assessment score in children (The scale is scored in a range of 0-10 with 0 representing no pain, 10 representing maximum pain)	24 hours
Secondary	additional analgesic consumption	total analgesic consuption within 24 hours	24 hours
Secondary	postoperative sedation scores RAMSEY (Ramsey sedation scale)	patient's sedation scores within postoperative first one hour (Ramsey sedation score is scored in a range of 1-6 with 1 representing awake; agitated or restless, 6 representing Asleep; no response to glabellar tap or loud auditory stimulus)	1 hour
Secondary	incidence of complications	Incidence of intraoperative and postoperative complications or side effects	24 hours