A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Bone Fracture Clinical Trial

Official title:

A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05751304
• Other study ID #: Soh-Med-23-02-09
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Sohag University
• Contact: zeyad A Ali, Resident
• Phone: 01159596946
• Email: zeyadahmed[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

-The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .

Exclusion Criteria:

• Patient refusal.
• Drug abuse.
• Patient with neurological, psychiatric or neuromuscular disease.
• Chronic pain on medicine.
• Known allergy to the study medications.
• Patients e contraindications to intrathecal anesthesia .

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

Intervention

Drug:
• Dexmedetomidine
(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 5µg Dexametomidine.
• Ketamine
(50 patients) will receive calculated dose of intrathecal hyperbaric bupivacaine 0.5 % according to body weight and 0.1 mg/kg ketamine.

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available. — View Citation

Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55. — View Citation

Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available. — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery	comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery.	1 year