Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain on Propofol Injection (POPI)
• Intervention / Treatment: Drug: Propofol Injection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: karim hu mourad, MD; Phone Number: 00201007451161; Email: karim.ghaleb87@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11956
    • Recruiting
    • Faculty of Medicine- Cairo University
    • Contact: karim hu mourad, MD; Phone Number: 00201007451161; Email: karim.ghaleb87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Patients aged 18 to 65 years old. 2. Patients classified as ASA I or II.

Exclusion Criteria:

• 1. Patients with the history of allergy to propofol or lignocaine. 2. Patients took any medication for analgesia or sedation in the past 24 hours. 3. Body mass index (BMI) more than 30. 4. Patients classified as ASA III & IV. 5 . Severe mental illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group (L); receive 3 ml (60 mg) of lignocaine 2% added to propofol during injection	Drug: Propofol Injection; adding lignocaine or sodium bicarbonate to propofol to reduce pain during injection
ACTIVE_COMPARATOR: Group (B); receive 3 ml of sodium bicarbonate 8.5% added to propofol during injection	Drug: Propofol Injection; adding lignocaine or sodium bicarbonate to propofol to reduce pain during injection
PLACEBO_COMPARATOR: Group (S); receive 3 ml of normal saline added to propofol during injection	Drug: Propofol Injection; adding lignocaine or sodium bicarbonate to propofol to reduce pain during injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating and Blood pressure	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	5 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (ACTUAL): August 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: lignocaine, sodium bicarbonate.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: Pain during propofol injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No