Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection

NCT ID: NCT05486819

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-02-02

Brief Summary

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

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.

Conditions

Propofol Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group (L)

receive 3 ml (60 mg) of lignocaine 2% added to propofol during injection

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

Group (B)

receive 3 ml of sodium bicarbonate 8.5% added to propofol during injection

Group Type: ACTIVE_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

Group (S)

receive 3 ml of normal saline added to propofol during injection

Group Type: PLACEBO_COMPARATOR

Propofol Injection

Intervention Type: DRUG

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

Interventions

Propofol Injection

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Karim Hussein

lecturer of anesthesia , surgical icu and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine- Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Pain during propofol injection

Identifier Type: -

Identifier Source: org_study_id