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Completed

NCT Number: NCT03265886

The Influence of Warm Bupivacaine 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.

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Key information

Conditions

Surgery to the Distal One Third of the Upper Limb

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University, Faculty of Medicine

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warm bupivacaine at (37°c)

Drug

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.

Bupivacaine at operating room temperature (23°c)

Drug

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.

Primary outcomes

  1. Time to onset of sensory block

    Time frame: for 30 min following injection

    defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)

Secondary outcomes

  1. Time to onset of motor block

    Time frame: For 3 hours after the injection of local anesthetic

    defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.

  2. Heart rate

    Time frame: For 3 hours after the injection of local anesthetic

  3. Blood pressure

    Time frame: For 3 hours after the injection of local anesthetic

  4. oxygen saturation in the peripheral blood

    Time frame: For 3 hours after the injection of local anesthetic

  5. Duration of sensory block

    Time frame: For 24 hours after the injection of local anesthetic

    defined as the interval between end of injection and complete end of sensory block (score=2)

  6. Duration of motor block

    Time frame: For 24 hours after the injection of local anesthetic

    defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.

  7. The severity of postoperative pain

    Time frame: For 24 hours after the injection of local anesthetic

    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.

  8. Time for first analgesic request

    Time frame: For 24 hours after the injection of local anesthetic

    Time to the first receiving of rescue analgesic from the time of blockade

  9. Total analgesics received

    Time frame: for 24 hrs after the injection of local anesthetic

    Cumulative use of rescue analgesics after performing the blockade

  10. Satisfaction Score

    Time frame: for 48 hrs after the injection of local anesthetic

    Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.