The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia

NCT03790163 | Unknown

• 1 other identifier: MFM.IRB,R/18.11.340
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to evaluate the effect of different temperature on the spinal anesthesia characteristics and incidence of complications

Conditions

Spinal Anesthetic Toxicity

Keywords

levobupivacaine,spinal anesthesia ,temperature

Outcome Measures

Primary Outcomes (1)

• Time to onset of sensory block

  Defined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)

  For 10 minutes following the spinal anesthesia

Secondary Outcomes (4)

• Time to the onset of motor block

  For 10 minutes following the injection of spinal anesthesia

• Duration of sensory block

  For 24 hours after the spinal anesthesia

• Duration of motor block

  For 24 hours after the spinal anesthesia

• Post spinal shivering

  for 24 hours after spinal anesthesia

Study Arms (3)

levobupivacaine at ( 23˚C)

PLACEBO COMPARATOR

Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered

Drug: Levobupivacaine

Warm levobupivacaine at (30˚C)

ACTIVE COMPARATOR

Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (30˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia

Drug: Levobupivacaine

Warm levobupivacaine at (37˚C)

ACTIVE COMPARATOR

Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (37˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia

Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)

Also known as: Chirocaine

Warm levobupivacaine at (30˚C); Warm levobupivacaine at (37˚C); levobupivacaine at ( 23˚C)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA-I or II

You may not qualify if:

• patient refusal; Any known hypersensitivity or contraindication to levobupivacaine pregnancy bleeding disorders local skin infections. Sepsis at the site of injection Coagulation abnormality Psychiatric disorders

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Adham Elgeidi

Al Mansurah, Dakahliah, 35516, Egypt

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Reem El sharkawy

  lecturer of anesthesia and surgical intensive care ,faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adham Elgeidi

CONTACT

01061057973; elgeidi@doctors.org.uk

Medhat Messeha

CONTACT

01207788199; medhatmikha70@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double(participant ,care provider)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: December 31, 2018
• Study Start: January 15, 2019
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

EG (1)