Isobaric Spinal Ropivacaine Versus Hyperbaric Spinal Bupivacaine in Total Knee Arthroplasty in Geriatric Patients

NCT02764723 | Completed

• 1 other identifier: MSAT-3
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of spinal anesthesia with isobaric ropivacaine, compared with hyperbaric bupivacaine in geriatric patients undergoing lower limb orthopedic surgery.

Conditions

Total Knee Arthroplasty in Geriatric Patients; Spinal Anesthesia

Outcome Measures

Primary Outcomes (5)

• Changes in the extent and duration of sensory block

  The assessment of sensory block to pinprick was performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection and then every 15 min until regression to L5. Results of the pinprick test were determined bilaterally at midclavicular level by using a short-beveled 27-gauge needle. Response to pain we determined by asking the patient whether or not he feels pain with the pinprick.

  within 2 years

• Changes in the extent and duration of motor block

  Motor block in the lower limb was assessed by using a modified Bromage scale (0 = no paralysis , 1 = unable to raise extended leg , 2 = unable to flex knee , 3 = unable to flex ankle). These assessments were performed immediately after the assessments of sensory block until the return of normal motor function.

  within 2 years

• Changes in the heart rate

  All patients of these 2 groups were assessed and monitored for Haemodynamics using ECG for heart rate (HR). Baseline values were defined as heart rate values before the preanesthetic infusion. The values were recorded before the induction and then every 5 min until discharge from the recovery room.

  within 2 years

• Changes in the non invasive mean arterial blood pressure

  All patients of these 2 groups were assessed and monitored for Haemodynamics as regards non invasive mean arterial blood pressure (MAP). Baseline values were defined as blood pressure values before the preanesthetic infusion. The values were recorded before the induction and then every 5 min until discharge from the recovery room.

  within 2 years

• Respiratory depression

  Respiratory depression (defined as respiratory rate \< 8 min and SPO 2 \< 90%)

  within 2 years

Study Arms (2)

Hyperbaric bupivacaine

ACTIVE COMPARATOR

12.5 mg of 0.5% hyperbaric bupivacaine

Drug: Hyperbaric bupivacaine

Isobaric ropivacaine

EXPERIMENTAL

15 mg of 0.5% isobaric ropivacaine

Drug: Isobaric ropivacaine

Interventions

Hyperbaric bupivacaine DRUG

12.5 mg of hyperbaric bupivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Hyperbaric bupivacaine

Isobaric ropivacaine DRUG

15 mg of isobaric ropivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Isobaric ropivacaine

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists physical status II-III aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

You may not qualify if:

• Known hypersensitivity to amide local anesthetics and contraindications to spinal anesthesia.

Sponsors & Collaborators

• Mohamed Sayed Mohamed Abbas: lead

Related Publications (1)

• D'Souza AD, Saldanha NM, Monteiro AD. Comparison of Intrathecal Hyperbaric 0.5% Bupivacaine, Isobaric 0.5% Levobupivacaine and Isobaric 0.75% Ropivacaine for Lower Abdominal Surgeries. International Journal of Health Sciences and Research (IJHSR). 2014;4(1):22-9.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 7, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share