The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics

The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics

Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.

The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.

Study Overview

• Status: Completed
• Conditions: Surgery to the Distal One Third of the Upper Limb
• Intervention / Treatment: Drug: Warm bupivacaine at (37°c); Drug: Bupivacaine at operating room temperature (23°c)

Detailed Description

The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists physical class I or II

Exclusion Criteria:

• Patient refusal.
• Pregnancy
• Neuromuscular diseases (as myopathies, myasthenia gravies…)
• Hematological diseases
• Bleeding disorders
• Coagulation abnormality.
• Psychiatric diseases.
• Local skin infection
• Sepsis at site of the block.
• Known intolerance to the study drugs.
• Body Mass Index > 40 Kg/m2.
• Bilateral upper limb injury to be performed at the same procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm bupivacaine at (37°c); Warmed bupivacaine at body temperature will be administered	Drug: Warm bupivacaine at (37°c); Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
Active Comparator: Bupivacaine at operating room temperature (23°c); Bupivacaine at temperature of 23°C will be administered	Drug: Bupivacaine at operating room temperature (23°c); Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of sensory block	defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)	for 30 min following injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of motor block	defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.	For 3 hours after the injection of local anesthetic
Heart rate		For 3 hours after the injection of local anesthetic
Blood pressure		For 3 hours after the injection of local anesthetic
oxygen saturation in the peripheral blood		For 3 hours after the injection of local anesthetic
Duration of sensory block	defined as the interval between end of injection and complete end of sensory block (score=2)	For 24 hours after the injection of local anesthetic
Duration of motor block	defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.	For 24 hours after the injection of local anesthetic
The severity of postoperative pain	will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.	For 24 hours after the injection of local anesthetic
Time for first analgesic request	Time to the first receiving of rescue analgesic from the time of blockade	For 24 hours after the injection of local anesthetic
Total analgesics received	Cumulative use of rescue analgesics after performing the blockade	for 24 hrs after the injection of local anesthetic
Satisfaction Score	Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor	for 48 hrs after the injection of local anesthetic

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Mohamed Y Makharita, MD, Professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): June 9, 2018
• Study Completion (Actual): September 17, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MFM-IRB, MS/17.05.143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: do not mind sharing raw data but after its publication not before.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No