Effect of Intrathecal Bupivacaine Temperature Variation on Prophylaxis of Shivering in Urologic Patients Undergoing Spinal Anesthesia
Launched by KASR EL AINI HOSPITAL · Jul 22, 2025
Trial Information
Current as of October 02, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether changing the temperature of a medicine called bupivacaine, which is injected into the spine during spinal anesthesia, can help prevent shivering after surgery. Shivering is a common side effect that some patients experience after spinal anesthesia, especially during urological procedures (surgeries involving the urinary system). The researchers want to see if warming or cooling the medicine before injection makes a difference in stopping shivering.
Adults aged 18 to 60 who are having urological surgery with spinal anesthesia and are generally healthy (classified as ASA class I or II, meaning they have no or mild health problems) may be eligible to join this study. People who have certain health issues like neurological problems, infections, bleeding disorders, kidney or liver diseases, or who refuse spinal anesthesia would not be able to participate. If you join, the medical team will give you spinal anesthesia as usual, but the temperature of the bupivacaine may be adjusted to see if it helps reduce shivering after surgery. This study is currently recruiting patients, and participation could help improve comfort for future patients undergoing similar procedures.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Adult patients scheduled for urological procedures under spinal anaesthesia. 2. Patient age ranges from 18 to 60 years. 3. American Society of Anesthesiologists (ASA) physical status class I or II.
- Exclusion Criteria:
- • 1. Patient's refusal of regional block. 2. Patients with neurological disorders, increased intracranial pressure, convulsive disorders, autonomic neuropathies, psychological disorders, or those lacking cooperation.
- • 3. Patients with anatomical abnormalities, skin lesions, wounds, or infection at the site of injection, or general infection.
- • 4. Patients with bleeding disorders defined as (INR\>1.4) and/or (platelet count \< 100,000/µL).
- • 5. Patients with known hypersensitivity to any of the study drugs. 6. Patients with renal impairment. 7. Patients with hepatic disease e.g. severe liver cell failure, or hepatic malignancy, or hepatic enlargement.
- • 8. Patients with failed, or partial spinal block.
About Kasr El Aini Hospital
Kasr El Aini Hospital, a prestigious medical institution affiliated with Cairo University, is dedicated to advancing healthcare through innovative clinical research. With a commitment to excellence, the hospital serves as a leading sponsor of clinical trials, leveraging its state-of-the-art facilities and a multidisciplinary team of healthcare professionals. The institution focuses on a diverse range of therapeutic areas, aiming to improve patient outcomes and contribute to the global medical community. By fostering collaboration and adhering to the highest ethical standards, Kasr El Aini Hospital plays a pivotal role in the development of new treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, Al Qahirah, Egypt
Patients applied
Trial Officials
Emad Mohamed Emad M. Abdelhafez00, Lecturer
Principal Investigator
Cairo University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported