Clinical trial NCT04194320: Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block
Official title: Nalbuphine Versus Dexamethasone as an Adjuvant to Lidocaine / Bupivacaine Mixture in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: First 24 hours after surgery
Secondary outcomes:
measure: post operative pain score "Visual Analogue Score"
timeFrame: First 24 hours after surgery
measure: The total opioid consumption
timeFrame: First 24 hours after surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, Zagazig University
state: Al-Sharkia
Study officials:
affiliation: Faculty of medicine, zagazig university, Egypt
name: Mohamed ELSayed, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, zagazig university, Egypt
name: Ahmed mohamed Salama, MD
role: STUDY_CHAIR
affiliation: Faculty of medicine, zagazig university, Egypt
name: Ayman Abd-El Salam Hassan, MD
role: STUDY_CHAIR
affiliation: Faculty of medicine, zagazig university, Egypt
name: Fatma Mahmoud Ahmed, MD
role: STUDY_DIRECTOR
References:
citation: Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.
citation: Das A, RoyBasunia S, Mukherjee A, Biswas H, Biswas R, Mitra T, Chattopadhyay S, Mandal SK. Perineural Nalbuphine in Ambulatory Upper Limb Surgery: A Comparison of Effects of Levobupivacaine with and without Nalbuphine as Adjuvant in Supraclavicular Brachial Plexus Block - A Prospective, Double-blinded, Randomized Controlled Study. Anesth Essays Res. 2017 Jan-Mar;11(1):40-46. doi: 10.4103/0259-1162.200225.
citation: Perlas A, Lobo G, Lo N, Brull R, Chan VW, Karkhanis R. Ultrasound-guided supraclavicular block: outcome of 510 consecutive cases. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):171-6. doi: 10.1097/AAP.0b013e31819a3f81.