Effect of Intrathecal Bupivacaine Temperature Variation on Prophylaxis of Shivering in Urologic Patients Undergoing Spinal Anesthesia

NCT07081516 | Completed

• 1 other identifier: MS-4-2025
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of temperature variation of injected intrathecal bupivacaine on prophylaxis of post-spinal shivering in urological patients undergoing spinal anaesthesia.

Conditions

Shivering, Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Shivering

  the incidence of grade 3 or 4 shivering which will be assessed at 10min intervals starting from the time of spinal block (T0) till the discharge from PACU. and it will be graded according to Wrench scale for shivering. Grade 0: No Shivering. Grade 1: One or more of the following: Piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity Grade 2: Visible muscle activity confined to one muscle group Grade 3: Visible muscle activity in more than 1 muscle group Grade 4: Gross muscle activity involving the whole body.

  starting from the time of the spinal injection (T0) till the discharge from the PACU

Study Arms (3)

Group A (cold group)patients will be given 15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (4°C) temp

ACTIVE COMPARATOR

Procedure: temperature

Group B (Room temp group) patients given 15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (24°C) temp

ACTIVE COMPARATOR

Procedure: temperature

Group C (Warm group) patients given15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (37 °C) temp

ACTIVE COMPARATOR

Procedure: temperature

Interventions

temperature PROCEDURE

Adjusting the temperature of the local anesthetic drugs injected intrathecally

Group A (cold group)patients will be given 15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (4°C) temp; Group B (Room temp group) patients given 15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (24°C) temp; Group C (Warm group) patients given15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (37 °C) temp

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Patient's refusal of regional block. 2. Patients with neurological disorders, increased intracranial pressure, convulsive disorders, autonomic neuropathies, psychological disorders, or those lacking cooperation.
• \. Patients with anatomical abnormalities, skin lesions, wounds, or infection at the site of injection, or general infection.
• \. Patients with bleeding disorders defined as (INR\>1.4) and/or (platelet count \< 100,000/µL).
• \. 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.
• \. Patients with failed, or partial spinal block.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy Hospitals

Cairo, Cairo Governorate, 1234, Egypt

Location

MeSH Terms

Interventions

Temperature

Intervention Hierarchy (Ancestors)

Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Environment and Public Health

Study Officials

• Emad Mohamed Emad M. Abdelhafez00, Lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Critical Care and Pain Management

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 23, 2025
• Study Start: April 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

EG (1)