Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics

NCT06382220 | Completed Phase 1

• 1 other identifier: R550
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications . Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade. Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration, The aim of this study To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people.

Conditions

Recruitment

Outcome Measures

Primary Outcomes (1)

• The rate of occurrence of hypotension

  mean arterial blood pressure

  intraoperative

Study Arms (2)

Group (A) Bupivacaine group

ACTIVE COMPARATOR

who received 7.5 mg (low dose) hyperbaric bupivacaine 0.5%

Drug: Bupivacain

Group (B) Prilocaine group

ACTIVE COMPARATOR

patients received 40 mg (low dose) intrathecal hyperbaric prilocaine

Drug: Bupivacain

Interventions

Bupivacain DRUG

drug injection

Also known as: prilocaine

Group (A) Bupivacaine group; Group (B) Prilocaine group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elderly patients (60 years old or above)
• either gender
• American Society of Anesthesiologists (ASA) physical status I, II, and III who were scheduled for elective knee and below knee orthopedic surgeries expected to the last for 40-60 min under spinal anesthesia.

You may not qualify if:

• Patients height \< 1.55 or \> 1.75 m,
• with other neurological diseases, spine abnormalities,
• absolute, and relative contraindications to spinal anesthesia as patients suffering from intracranial hypertension, major bleeding disorder, patients on anticoagulant, local infection, dementia, and allergic reaction to local anesthetics.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

Related Publications (2)

• Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.

  PMID: 22713634 BACKGROUND

• Neuman MD, Fleisher LA, Even-Shoshan O, Mi L, Silber JH. Nonoperative care for hip fracture in the elderly: the influence of race, income, and comorbidities. Med Care. 2010 Apr;48(4):314-20. doi: 10.1097/mlr.0b013e3181ca4126.

  PMID: 20355262 RESULT

MeSH Terms

Interventions

Bupivacaine; Prilocaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 23, 2024
• Primary Completion: July 25, 2024
• Study Completion: August 15, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)