Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery

NCT06865469 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Dex vs lidocaine fracture hip
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Perioperative pain management has been a major challenge for anesthesiologists, and there have been persistent efforts to bring out the best possible analgesic technique with the least side effects. Hip fractures are devastating injuries, constituting a global public health burden and remain one of the largest healthcare challenges of the 21st century. The incidence increases with advancing age and the number of hip fractures is expected to increase to 6.26 million per year in 2050. Hip fractures impact on patient's psychological, functional, and social wellbeing, and account for substantial healthcare system costs. Drugs of potential interest such as intravenous (i.v.) lidocaine and dexmedetomidine have been administered both intra and/or postoperatively to decrease perioperative pain and improve other outcomes. Lidoocaine has analgesic, anti inflammatory, and anti hyperalgesia properties. Several studies have demonstrated that perioperative lidocaine infusion reduces postoperative pain intensity and opioid consumption . Ease of availability, cost effectiveness, simplicity of administration, safety, and analgesic action make lignocaine an attractive option. Dexmedetomidine is a highly selective and specific α2 adrenoceptor agonist with useful analgesic, sedative, anxiolytic, and sympatholytic properties. I.V. dexmedetomidine has gained immense popularity owing to its efficacy as an analgesic adjuvant, translating into reduced opioid consumption. Intraoperative dexmedetomidine and lignocaine also confirm the enhanced recovery after surgery protocol advocating the reduction of opioid use. While numerous studies have analyzed i.v. lidoocaine and dexmedetomidine versus placebo regarding postoperative analgesia and outcomes, researches and evidence in the context of minimally invasive surgeries regarding adverse effect profile, postoperative analgesic requirement, perioperative analgesia, anesthesia recovery, and opioid requirements are always welcome(rephrase). Our study was conducted to analyze the effects of intraoperative i.v. lidocaine and dexmedetomidine on pain relief, intra- and postoperative opioid consumption, and effects of these infusions on intraoperative hemodynamic parameters and to evaluate the side effect profiles the aim of the study to analyze the effects of intraoperative intravenous lignocaine/dexmedetomidine on postoperative pain relief and analgesit consumption

Conditions

Fracture Hip Surgery

Outcome Measures

Primary Outcomes (1)

• pain score NRS score

  The severity of pain will be assessed postoperatively using a 10 cm NRS (0 = no pain and 10 = worst imaginable pain) at rest and coughing at 0, 2nd, 4th, 6th, 12th, 18th, and 24th hours

  24 hours

Study Arms (2)

Group D

ACTIVE COMPARATOR

patients will recive dexmedetomidine i.v. infusion at 0.4 μg/kg/h

Drug: Dexmedetomidine

Group L

ACTIVE COMPARATOR

patients will received 1.5 mg/kg/h lidocaine hydrochloride 2% (400 mg/20 mL) by i.v. infusion.

Drug: Lidocaine Hydrochloride 2%

Interventions

Dexmedetomidine DRUG

dexmedetomidine will be administered by i.v. infusion at 0.4 μg/kg/h

Group D

Lidocaine Hydrochloride 2% DRUG

lidocaine hydrochloride 2% (400 mg/20 mL) 1.5 mg/kg/h by i.v. infusion.

Group L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years old.
• patients with both sex
• patients who are American society of Anesthesiologists class I or II

You may not qualify if:

• refusal.
• body mass index (BMI) ≥40 kg/m2.
• History of hypersensitivity to the drugs being evaluated
• Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.
• chronic use of opioids and opioid addiction

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine; Lidocaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03