Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Z

Zagazig University

Status

Completed

Conditions

Anesthesia

Treatments

Procedure: Ultrasound (US) guided supraclavicular brachial plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT04194320
Brachial Plexus Block

Details and patient eligibility

About

Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of dexamethasone or nalbuphine as adjuvants to local anesthetics in supraclavicular brachial plexus block for upper limb surgeries.

Full description

Upper-limb surgeries can be performed under either general or regional anesthesia.However, regional anesthesia has the advantages of long-lasting pain relief & avoidance of airway instrumentation.Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to local anesthetics mixture (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in Ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries below the level of the shoulder.

Enrollment

45 patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient acceptance.
  • American Society of Anesthesiologists (ASA) I and (ASA) II.
  • Age 21-60 years old.
  • Both gender.
  • BMI < 30.
  • Accepted mental state of the patient.
  • Unilateral upper limb surgeries below the level of the shoulder.

Exclusion criteria

  • Patient refusal.
  • Peripheral neuropathy.
  • Pathological coagulopathy.
  • Infection at the injection site.
  • History of active substance abuse.
  • Untreated pneumothorax.
  • Disturbed conscious level.
  • An allergy to local anesthetics or nalbuphine or dexamethasone.
  • Planned for receiving general anesthesia during the same operation for any cause.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups, including a placebo group

Group I "Placebo"
Placebo Comparator group
Description:
Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 2 ml 0.9% normal saline.
Treatment:
Procedure: Ultrasound (US) guided supraclavicular brachial plexus block
Group II "Nalbuphine "
Active Comparator group
Description:
Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 10 mg nalbuphine hydrochloride (completed to 2 ml with 0.9% normal saline).
Treatment:
Procedure: Ultrasound (US) guided supraclavicular brachial plexus block
Group III "Dexamethasone"
Active Comparator group
Description:
Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 2 mL dexamethasone 0.4% (8 mg).
Treatment:
Procedure: Ultrasound (US) guided supraclavicular brachial plexus block

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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