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Search / Trial NCT07081516

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.

Locations

Cairo, Al Qahirah, Egypt

Patients applied

0 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