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Completed

NCT Number: NCT05486819

Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection

To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine- Cairo University

Cairo, 11956, Egypt

About this study

Propofol is the most commonly used intravenous (IV) anesthetic drug for induction of anesthesia and for sedation. It is almost an ideal IV anesthetic agent, but pain which occur during its injection still remains a problem. This pain may not be a serious complication, but most patients remember it as an unpleasant encounter with anesthetists. In one survey, pain on propofol injection (POPI) stands 7th most important problem in the current practice of anesthesia . About 70 to 90% of patients who were given propofol for anesthesia induction experience pain during injection and this pain can be quite severe. All phenols irritate skin and mucous membranes. Thus, propofol being an alkyl-phenol is expected to induce pain despite the fact that it is almost isotonic. POPI has also been described as angialgia which means that the pain is due to vascular involvement . POPI is immediate as well as delayed after 10-20 seconds . The immediate pain is due to irritation of vein endothelium while as delayed pain is due to the release of mediators such a kininogen from kinin cascade . The most frequently used drug to alleviate POPI is intravenous lignocaine. The use of lignocaine to decrease POPI is due to its local anesthetic effect on the veins. However, it does not alleviate pain effectively in about 40% of the patients treated in this way (2). Administration of sodium bicarbonate was proved to reduce POPI. The proposed mechanism is through increasing sodium ions concentration as well as increasing serum pH through its buffering effect.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 to 65 years old.
  • Patients classified as ASA I or II.

Exclusion criteria

  • Patients with the history of allergy to propofol or lignocaine.
  • Patients took any medication for analgesia or sedation in the past 24 hours.
  • Body mass index (BMI) more than 30.
  • Patients classified as ASA III & IV.
  • Severe mental illness.

Treatment and study plan

Propofol Injection

Drug

adding lignocaine or sodium bicarbonate to propofol to reduce pain during injection

Primary outcomes

  1. measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating

    Time frame: 5 months

Secondary outcomes

  1. 1. Pain intensity at any top up doses of propofol. 2. Heart rate: baseline, 5 seconds, 1 minute & 5 minutes after injection. 3. Blood pressure: baseline, immediately after assessing the pain score then 5 minutes later

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Lignocaine Versus Sodium Bicarbonate on Reducing Pain Due to Intravenous Injection of Propofol : a Prospective Randomised Double-blinded, Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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