Ketamine and Dexmedetomidine Comparative Study

NCT06032624 | Unknown

• 1 other identifier: Soh-Med-22-07-34
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, the investigators will compare the effect of adding ketamine and dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as regards the onset and duration of the block, postoperative visual analogue scale, and analgesic consumption.50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• the onset of the femoral nerve block

  The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.

  from the deposition of the local anesthetic till the loss of pinprick sensation

Study Arms (2)

Ketamine group (group K)

ACTIVE COMPARATOR

Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\\kg ketamine.

Procedure: combined ultra-sound guided femoral and sciatic nerve block.

Dexmedetomidine group (group D)

ACTIVE COMPARATOR

Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\\kg dexmedetomidine.

Procedure: combined ultra-sound guided femoral and sciatic nerve block.

Interventions

combined ultra-sound guided femoral and sciatic nerve block. PROCEDURE

Femoral nerve block, The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm, and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., the volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block, A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences,A volume of 25 ml of bupivacaine will be injected to perform the block.

Dexmedetomidine group (group D); Ketamine group (group K)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.

You may not qualify if:

• Patient refusal.
• Patient with significant neurological, psychiatric or neuromuscular disease.
• Alcoholism.
• Drug abuse.
• Pregnancy or lactating women.
• Suspected Coagulopathy.
• Morbid obesity.
• Known allergy to study medications.
• Septicaemia and local infection at the block site.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mohammed Mahmoud, MD

CONTACT

00201091328413; mohamedmahmoud@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: September 13, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09