CompletedNot Applicable

Effect of Buffered Lidocaine With Epinephrine in Local Anesthesia

120 participantsStarted 2017-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

T1 pain intensity

Timeframe: Immediately after local anesthetic infiltration

T2 pain intensity

Timeframe: Immediately after central vein cannulation

T3 pain intensity

Timeframe: Immediately after skin incision,

T4 pain intensity

Timeframe: Immediately after deep tissue dissection and pocket formation,

T5 pain intensity

Timeframe: Immediately after skin closure.

Trial details

NCT IDNCT03628430

SponsorFaculty of Medicine, Sousse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-30

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