Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia

August 9, 2018 updated by: Mohamed Kahloul, Faculty of Medicine, Sousse

Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia During Subcutaneous Implantable Venous Access Devices Insertion: Double Blind Randomized Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized, controlled, double-blinded study was carried out in the Anesthesia and Resuscitation Department of Farhat Hached University Hospital of Sousse over a period of 6 months (1st January 2017 to 30th June 2017). Ethical approval was obtained from the institution's Research Ethics Board. Written informed consent was obtained from each patient by the investigators before entering this study. Outpatients, aged over 18 years, scheduled for Porta-Cath (PAC) insertion under local anesthesia were included.

Apart from the 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 or those with severe cardiovascular and respiratory compromise or having a neuropathy were excluded from the study.

The study subjects randomly received, in a double blind manner (using computer-generated allocation numbers sealed in brown envelopes), one of two local anesthetic solutions. The pH adjusted group (group A) received 5 mL of 4.2 % sodium bicarbonate added to 10 mL of 2% lidocaine with epinephrine 0.005mg/ml (Lidocaine adrenaline; Aguettant, France) and the control group (group C) received 5 mL of 0.9% NaCl added to 10 mL of 2% lidocaine with epinephrine 0.005mg/ml (Lidocaine adrenaline; Aguettant, France).

Local anesthetic solutions were freshly prepared by a member of the anesthesia team and balanced at room temperature 30 minute prior to the procedure, whereas the anesthetist in charge of the patient was unaware of the prepared solution. The pH values of the final formulations have been measured using a pH-meter (PH-meter/millivoltmeter 3510 JENWAY) at the beginning of the study; it was 3.5 in the control group and 7.33 in the study group.

Routine monitoring included heart rate, blood pressure, oxyhemoglobin saturation, and respiratory rate were applied at arrival in the operating room. The process has been carried out in conditions of surgical asepsis. The preparation of the insertion area of the PAC included a prerequisite depilation, a cleaning of the area, rinsing, drying, an application of an antiseptic and then the setting of sterile drapes widely extending beyond the catheterization area. No preoperative sedation was administered. There was no pretreatment of the skin with any type of topical anesthetic or pain reducing technique before the injection of the anesthetic mixture.

The operator was provided with a syringe containing one of the randomly assigned local anesthetics. After confirming suitability of the target subclavian vein by ultrasound, the operator injected 3 mL of the local anesthetic solution through a 25 gauge needle directly superficial to the subclavian vein with ultrasound guidance. This injection was deliberate and not rushed, lasting 10 sec, with the same angle of injection with regard to the skin. The needle was then repositioned to inject 12mL to infiltrate the skin and deep tissue of the targeted area of the anterior chest wall. Each patient received a 7 Fr catheter via a non-tunneled approach. Each patient underwent instruction on rating pain and satisfaction via a standardized 100 mm horizontal linear visual analog scale (VAS) in which a score of 0 represented no pain / not satisfied and 100 represented the worst possible pain /very satisfied.

The primary outcome of this study was pain assessed on VAS at five procedural steps: 1) local anesthetic infiltration, 2) central vein cannulation, 3) skin incision, 4) deep tissue dissection and pocket formation, and 5) skin closure. Secondary outcomes were sensory block onset time using pinprick test and patients' satisfaction.

The required sample size was calculated hoping for a decrease of 30 mm of the VAS score during the injection of the local anesthetic after alkalinization, with a power (1-β) of 90%, a non-directional risk α of 5%, and assuming a standard deviation of 42, the size of the sample per group was estimated at 42. The sample size was increased to 60 patients per group in order to prevent the possible missing data or violation of the protocol.

Data were collected on customized data collection sheets and analyzed by the dedicated statistical software (IBM® Statistical Package for Social Science (SPSS), version 21.0, New York, USA). A p value of 0.05 was considered statistically significant. The quantitative variables were expressed in average and standard deviation. The qualitative variables were expressed in numbers and percentage. In order to compare qualitative variables, Pearson Chi-2 test was used. Student's t-test was used to compare quantitative variables.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C

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
Local anesthesia with lidocaine with epinephrine
Procedure: Normal saline
normal saline as adjuvant to lidocaine with epinephrine in Local anesthesia
Active Comparator: Group A

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
Local anesthesia with lidocaine with epinephrine
Procedure: sodium bicarbonate
sodium bicarbonate as adjuvant to lidocaine with epinephrine in Local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T1 pain intensity
Time Frame: Immediately after local anesthetic infiltration
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
Time Frame: Immediately after central vein cannulation
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
Time Frame: Immediately after skin incision,
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
Time Frame: Immediately after deep tissue dissection and pocket formation,
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
Time Frame: Immediately after skin closure.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory block onset time
Time Frame: up to one hour after the intervention
sensory block onset time assessed by pinprick test
up to one hour after the intervention
patients' satisfaction.
Time Frame: Immediately after the intervention
patients' satisfaction assessed by a 100 mm visual analog scale (VAS) ranging from 0 (not satisfied) to 100 (very satisfied).
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

August 7, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFH2922016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on lidocaine with epinephrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe