Effect of Lidocaine in Reducing Opioids Requirement in Day Care Surgery

NCT06717672 | Completed Phase 3

• 1 other identifier: ANS-2021-192-2750
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.\*Reduced opioid consumption
2. 2.\*Decreased pain scores
3. 3.\*Fewer opioid-related side effects
4. 4.\*Improved patient satisfaction

Conditions

Pain; Post-operative Pain Control; Post-operative Pain

Keywords

Lidocaine; Opiods; Peri-operative pain; Decrease Opioid requirement; Ambulatory surgeries

Outcome Measures

Primary Outcomes (1)

• Peri-operative pain

  Visual Analog pain scale to rate pain scale comprises 0 to 10 score 0 minimum to 10 Maximum

  at 2 hours, 4 hours, 6 hours

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

intervention group recieve inj lidocaine

Drug: Lidocaine 2% without vessel constrictor

Control group

PLACEBO COMPARATOR

control group receive Normal saline

Drug: Normal Saline

Interventions

Lidocaine 2% without vessel constrictor DRUG

1. \_Lidocaine 2% provides rapid and effective local anesthesia for minor surgical procedures, such as biopsies, excisions, and suturing. 2. \_Pain relief\_: Lidocaine 2% has been shown to provide significant pain relief in patients with acute pain, such as post-operative pain, trauma, and burns. 3. \_Reducing pain intensity\_: Lidocaine 2% has been shown to reduce pain intensity by 30-50% in various clinical studies.

Intervention group

Normal Saline DRUG

Normal saline used is an iv fluid given for fluid replacement

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 and 2
• patient age between 18 and 65 years
• Patient undergoing ambulatory surgeries

You may not qualify if:

• Pregnant women
• Allergic to Lidocaine Patient who had fever and treated with antibiotic and steroid in last month

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Liaquat National Hospital and Medical College

Karachi, Sindh, Pakistan

Location

Related Links

• Systemic lidocaine decreased the perioperative opioid analgesic requirements but failed to reduce discharge time after ambulatory surgery Allannah McKay 1, Antje Gottschalk, Annette Ploppa, Marcel E Durieux, Danja S Groves

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hanesh Tanwani Dr Hanesh Tanwani

  Liaquat National Hospital and Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 5, 2024
• Study Start: November 5, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)