Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia

NCT03628430 | Completed

• 1 other identifier: HFH2922016
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subcutaneous implantable venous access devices are routinely implanted under local anesthesia. However, patients complain of pain during the injection of local anesthesia. The aim of this study was to evaluate the effectiveness of sodium bicarbonate-buffered lidocaine with epinephrine on reducing pain and patients' satisfaction during subcutaneous implantable venous access devices insertion. A prospective double-blind study was conducted over a period of 6 months (1st January 2017 to 30th June 2017). Patients were randomized to receive either buffered (PH= 7.33) or plane lidocaine (PH= 3.50). The same operator made all insertions using a standard technique. Pain at five procedural steps (local anesthetic infiltration, central vein cannulation, skin incision, deep tissue dissection and pocket formation, and skin closure) and satisfaction were evaluated on a VAS score (0-100 mm). Secondary outcomes were sensory block onset time using pinprick test and patients' satisfaction.

Conditions

Pain; Anesthesia, Local

Keywords

Anesthesia;; lidocaine;; patient experience; patient pain; sodium bicarbonate; Vascular Access Devices

Outcome Measures

Primary Outcomes (5)

• T1 pain intensity

  pain intensity assessed immediately after local anesthetic infiltration, by a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (the worst possible pain).

  Immediately after local anesthetic infiltration

• T2 pain intensity

  pain intensity assessed immediately after central vein cannulation, by a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (the worst possible pain).

  Immediately after central vein cannulation

• T3 pain intensity

  pain intensity assessed immediately after skin incision, by a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (the worst possible pain).

  Immediately after skin incision,

• T4 pain intensity

  pain intensity assessed immediately after deep tissue dissection and pocket formation, by a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (the worst possible pain).

  Immediately after deep tissue dissection and pocket formation,

• T5 pain intensity

  pain intensity assessed immediately after skin closure, by a 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (the worst possible pain).

  Immediately after skin closure.

Secondary Outcomes (2)

• sensory block onset time

  up to one hour after the intervention

• patients' satisfaction.

  Immediately after the intervention

Study Arms (2)

Group C

PLACEBO COMPARATOR

For patients of this group, the intervention was a Local Anesthesia with: * 10 mL of 2% lidocaine with epinephrine 0.005mg/ml * and 5 mL of 0.9% NaCl

Procedure: lidocaine with epinephrine; Procedure: Normal saline

Group A

ACTIVE COMPARATOR

For patients of this group, the intervention was a Local Anesthesia with: * 10 mL of 2% lidocaine with epinephrine 0.005mg/ml * and 5 mL of 4.2 % sodium bicarbonate

Procedure: lidocaine with epinephrine; Procedure: sodium bicarbonate

Interventions

lidocaine with epinephrine PROCEDURE

Local anesthesia with lidocaine with epinephrine

Group A; Group C

sodium bicarbonate PROCEDURE

sodium bicarbonate as adjuvant to lidocaine with epinephrine in Local anesthesia

Group A

Normal saline PROCEDURE

normal saline as adjuvant to lidocaine with epinephrine in Local anesthesia

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients, aged over 18 years, scheduled for PAC placement under local anesthesia

You may not qualify if:

• usual contraindications to PAC insertion,
• pregnant women,
• patients with a known allergy to study drugs,
• patients chronically using opioids or benzodiazepine for cancer or chronic pain,
• patients with history of thoracic or cervico-facial radiotherapy
• patients with severe cardiovascular and respiratory compromise
• patients having a neuropathy

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Related Publications (5)

• Kirk LM, Brown SD, Luu Y, Ogle A, Huffman J, Lewis PO. Beyond-use dating of lidocaine alone and in two "magic mouthwash" preparations. Am J Health Syst Pharm. 2017 May 1;74(9):e202-e210. doi: 10.2146/ajhp160214.

  PMID: 28438825 RESULT

• Phero JA, Nelson B, Davis B, Dunlop N, Phillips C, Reside G, Tikunov AP, White RP Jr. Buffered Versus Non-Buffered Lidocaine With Epinephrine for Mandibular Nerve Block: Clinical Outcomes. J Oral Maxillofac Surg. 2017 Apr;75(4):688-693. doi: 10.1016/j.joms.2016.09.055. Epub 2016 Oct 8.

  PMID: 27815105 RESULT

• Vasan A, Baker JA, Shelby RA, Soo MSC. Impact of Sodium Bicarbonate-Buffered Lidocaine on Patient Pain During Image-Guided Breast Biopsy. J Am Coll Radiol. 2017 Sep;14(9):1194-1201. doi: 10.1016/j.jacr.2017.03.026. Epub 2017 May 17.

  PMID: 28527821 RESULT

• Lee HJ, Cho YJ, Gong HS, Rhee SH, Park HS, Baek GH. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study. J Hand Surg Am. 2013 May;38(5):971-5. doi: 10.1016/j.jhsa.2013.02.016. Epub 2013 Apr 6.

  PMID: 23566722 RESULT

• Welch MN, Czyz CN, Kalwerisky K, Holck DE, Mihora LD. Double-blind, bilateral pain comparison with simultaneous injection of 2% lidocaine versus buffered 2% lidocaine for periocular anesthesia. Ophthalmology. 2012 Oct;119(10):2048-52. doi: 10.1016/j.ophtha.2012.05.029. Epub 2012 Jul 6.

  PMID: 22771049 RESULT

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Epinephrine; Sodium Bicarbonate; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: participants were assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 14, 2018

Record last verified: 2018-08