Analgesic Efficacy of Two Doses of Dexmedetomidine as Adjuncts to Lidocaine for Intravenous Regional Anesthesia

NCT03399474 | Completed Phase 4

• 1 other identifier: Assiut University Anathesia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous Regional Anesthesia (IVRA) was first used by August Bier in 1908. This technique is easy to administer, reliable and cost-effective for short surgical procedures of the extremities performed on an ambulatory basis with success rate of approximately 95% - 100% . Lidocaine becomes the local anesthetic of choice for Intravenous Regional Anesthesia (IVRA) because of the lack of cardiac toxicity and neurotoxicity. But, delayed onset of action, poor muscle relaxation and lack of postoperative analgesia are the major limitations of this technique. Accordingly, many additives have been tried to overcome this problem. Muscle relaxants, ketamine,ketorolac, clonidine and opioids are examples of these adjuvants, and their effects have been studied in detail. An ideal anesthetic agent for IVRA should have rapid analgesic effect to reduce tourniquet pain and its effects should last longer enough after deflating tourniquet. To achieve this, other drugs including narcotics, nonsteroidal anti-inflammatory drugs, ketorolac, clonidine, nitroglycerin (TNG), dexmedetomidine, magnesium, and neostigmine were used in combination with lidocaine in different studies. This study aims 1- To compare the anesthetic and analgesic efficacy of Dexmedetomidine and lidocaine versus lidocaine only during IVRA (Bier's block) and 2-To compare anesthetic and analgesic efficacy of different doses of dexmedetomidine when used as adjuvants to lidocaine during IVRA (Bier's block).

Conditions

Limb Deformity

Keywords

Regional Anesthesia, Dexmedetomidine and lidocaine

Outcome Measures

Primary Outcomes (1)

• The time to first analgesic request.

  if patients starts to complain (VAS \> 3); rescue analgesia will be given in the form of paracetamol (Perfalgan®) 1gm IV drip and/or diclofenac sodium (Voltaren®) 75 mg IM, and/or nalbuphine 5 mg IV (with maximum daily dose of 2 mg/Kg/day) till VAS ≤ 3.And total amount of nalbuphine administered in first 24 hours to each group will be recorded.

  24 hours

Secondary Outcomes (3)

• Pain due to the tourniquet assessed with visual analogue scale (VAS) scores before and after the application of tourniquet and during the operation

  24 hours

• Levels of sedation assessed with the Ramsey sedation scale before and after the application of tourniquet and during the operation

  24 hours

• The onset, duration times of both sensory and motor blocks, Sensory block onset time, Motor block onset time

  24 hours

Study Arms (3)

Lidocaine only

ACTIVE COMPARATOR

Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline for intravenous regional anesthesia.

Drug: Lidocaine Hydrochloride 2%

0.5 ug/kg dexmedetomidine

EXPERIMENTAL

Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline (maximum dose200 mg)+ Dexmedetomidine intravenous in a dose of 0.5 ug/kg, with the total volume diluted to 40 ml with normal saline 0.9%. The solution will be injected at a rate of 20 ml/min for intravenous regional anesthesia.

Drug: Dexmedetomidine 0.5 ug/kg

0.25 ug/kg dexmedetomidine

EXPERIMENTAL

1 Lidocaine intravenous in a dose of 3 mg/kg lidocaine 0.5% diluted in 40 ml isotonic saline (maximum dose200 mg)+ Dexmedetomidine intravenous in a dose of 0.25 ug/kg, with the total volume diluted to 40 ml with normal saline 0.9%. The solution will be injected at a rate of 20 ml/min. for intravenous regional anesthesia.

Drug: Dexmedetomidine Injection 0.25 ug/kg

Interventions

Lidocaine Hydrochloride 2% DRUG

Lidocaine Hydrochloride 2%

Lidocaine only

Dexmedetomidine 0.5 ug/kg DRUG

pecedex

0.5 ug/kg dexmedetomidine

Dexmedetomidine Injection 0.25 ug/kg DRUG

pecedex

0.25 ug/kg dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 20-60 years with American society of anesthesiologists physical status I or II undergoing minor hand or forearm surgeries (duration of surgery 60 min or less, such as carpal tunnel release, ganglion excision, trigger finger, tendon or nerve repair, and fracture finger or metacarpal bone) .

You may not qualify if:

• Patients with Raynaud's disease,
• history of drug allergy, sickle cell anemia, Liver diseases and kidney diseases
• Patients who had a history of allergy to the drugs used, recent or chronic use of analgesics,
• uncontrolled hypertension, diabetic neuropathy, peripheral ischemia, , or any psychological disturbances

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ghada M Ab Elfadl

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 16, 2018
• Study Start: March 1, 2018
• Primary Completion: July 30, 2020
• Study Completion: August 30, 2020
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

EG (1)