Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05486819

Collaborator

(none)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

25.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain on Propofol Injection (POPI)	Drug: Propofol Injection	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating and Blood pressure [5 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine- Cairo University	Cairo		Egypt	11956

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karim Hussein, lecturer of anesthesia , surgical icu and pain management, Cairo University

ClinicalTrials.gov Identifier:

NCT05486819

Other Study ID Numbers:

Pain during propofol injection

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Karim Hussein, lecturer of anesthesia , surgical icu and pain management, Cairo University

lignocaine, sodium bicarbonate.

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Aug 4, 2022