Spinal Hypobaric Local Anesthetic Study

NCT06166394 | Completed

• 2 other identifiers: 22-5558v04Nov2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The length of hospital stay after total hip and knee arthroplasty is determined based on the successful mobilization of the patients post surgery. Fast track pathways involving early mobilization and discharge of the patient on the same day of surgery, shortens the hospital stay and reduces the risk of adverse effects. The long acting LA (bupivacaine) is most commonly used in spinal anesthesia for arthroplasty surgeries and is associated with a prolonged motor and sensory block. In contrast, hypobaric bupivacaine and hypobaric mepivacaine helps in achieving the desired block level with smaller dosage and shorter onset time and faster recovery when compared to long acting local anesthetics. The aim of the study is to observe the effects of hypobaric local anesthetics ( bupivacaine and mepivacaine ) in patients undergoing unilateral total hip or knee arthroplasty in terms of time to onset and time to recovery of the block and also its effect on hemodynamic stability and time to mobilization after surgery. This study will allow the investigators to recommend optimal dosing strategies that in turn will help in faster recovery from spinal anesthesia and early mobilization thereby reducing harmful outcomes.

Conditions

Anesthesia, Local

Keywords

Spinal Hypobaric LA; Bupivacaine; Mepivacaine

Outcome Measures

Primary Outcomes (5)

• 1. Time to reach the most cephalad/cranial sensory block level (onset time of spinal anesthesia on the surgical side).

  Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.

  Assessed over the duration of time period till the patient is discharged.

• Time to reach sensory block level of L1 or higher (adequate level of anesthesia for knee surgery) on the surgical side

  Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.

  Assessed over the duration of time period till the patient is discharged.

• Time to reach sensory block level T10 or higher (adequate level of anesthesia for hip surgery) on the surgical side

  Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.

  Assessed over the duration of time period till the patient is discharged.

• The most cephalad/cranial sensory block level

  Sensory block will be assessed every 5 mins during the first 30 mins after spinal injection. A pinprick test using an 18G (Gauge) blunt-tipped needle (BD Blunt Fill needle) will be performed on non-dependent and dependent sides to detect sensory loss over the torso and lower limbs.

  Assessed over the duration of time period till the patient is discharged.

• Time to achieve complete motor block on the modified Bromage scale

  Time to onset is a continuous variable and therefore will be expressed as mean ± standard deviation.

  Assessed over the duration of time period till the patient is discharged.

Secondary Outcomes (7)

• Time to regression of the sensory block to the L2 dermatome on both lower limbs.

  Assessed over the duration of time period till the patient is discharged.

• Time to full motor recovery on the modified Bromage scale

  Assessed over the duration of time period till the patient is discharged.

• Hemodynamic stability after the spinal injection

  Assessed over the duration of time period till the patient is discharged.

• Time to ambulation

  Assessed over the duration of time period till the patient is discharged.

• Patient satisfaction score

  Assessed before the patient is discharged.

Study Arms (2)

Mepivacaine

Day surgery patients(30 patients); For these patients- Administration of a spinal hypobaric mepivacaine injection

Drug: Spinal hypobaric Mepivacaine Local Anesthetic Injection

Bupivacaine

In-patients(30 patients): For these patients- Administration of a spinal hypobaric bupivacaine injection

Drug: Spinal hypobaric Bupivacaine Local Anesthetic Injection

Interventions

Spinal hypobaric Mepivacaine Local Anesthetic Injection DRUG

• Administration of a hypobaric spinal mixture for Day-Surgery patients: 3.4ml of 1.5% mepivacaine created by 3ml 2% mepivacaine with 1ml sterile water, and then discarding 0.6ml

Also known as: Carbocaine

Mepivacaine

Spinal hypobaric Bupivacaine Local Anesthetic Injection DRUG

Administration of a hypobaric spinal mixture for In-patients: 3ml of 0.33% bupivacaine created by 2ml 0.5% bupivacaine with 1ml sterile water

Also known as: Marcaine

Bupivacaine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All day surgery and in-patients who are scheduled to undergo elective unilateral total hip or knee arthroplasty under spinal anesthesia at Toronto Western Hospital

You may qualify if:

• Patients undergoing elective unilateral total hip or knee arthroplasty under spinal anesthesia at Toronto Western Hospital
• American Society of Anesthesiologists physical status class (ASA-PS) 1-3
• Aged ≥ 20 years

You may not qualify if:

• Refusal to participate
• Inability to communicate due to language barrier or cognitive impairment
• Height \< 150 cm or \> 200 cm
• Weight \< 40 kg or \>130 kg
• Contraindication or allergy to amide-type local anesthetic
• Contraindication to spinal anesthesia (e.g., infection at the injection site, existing coagulopathy)
• Spinal anesthesia performed in the operating room rather than the block room (which will preclude adequate testing)
• Spinal anesthesia that includes administration of intrathecal opioids (e.g., morphine, fentanyl),so as to avoid unanticipated alterations in block quality or solution baricities.
• Pre-existing sensory or motor impairment in the lower extremities

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Interventions

Mepivacaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ki Jinn Chin, MD,FRCPC

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: June 9, 2023
• Primary Completion: October 17, 2023
• Study Completion: May 24, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)