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Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia

NCT03628430 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-08-14

No results posted yet for this study

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

Interventions

PROCEDURE

lidocaine with epinephrine

Local anesthesia with lidocaine with epinephrine

PROCEDURE

sodium bicarbonate

sodium bicarbonate as adjuvant to lidocaine with epinephrine in Local anesthesia

PROCEDURE

Normal saline

normal saline as adjuvant to lidocaine with epinephrine in Local anesthesia

Sponsors & Collaborators

  • Faculty of Medicine, Sousse

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-06-30
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03628430 on ClinicalTrials.gov