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

Isobaric Ropivacaine 15 mg Versus Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Geriatric Patients Undergoing Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Total Knee Arthroplasty in Geriatric Patients
• Intervention / Treatment: Drug: Hyperbaric bupivacaine; Drug: Isobaric ropivacaine

Detailed Description

52 patients physical status II-III according to the American Society of Anesthesiologists classification aged 65 years and above of average height, and scheduled for total knee replacement under spinal anesthesia.

Patients were randomly assigned into two equal groups of 26 patients each according to the type of local anesthetic injected in the subarachnoid space , Group I : patients who received an intrathecal injection of 12.5 mg of 0.5% hyperbaric bupivacaine , Group II: patients who received an intrathecal injection of 15 mg of 0.5% ropivacaine.

The investigators compared both groups as regards the extent and duration of sensory and motor block and hemodynamics including heart rate (HR) , non invasive mean arterial blood pressure (MAP) and respiratory depression.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyperbaric bupivacaine; 12.5 mg of 0.5% hyperbaric bupivacaine	Drug: Hyperbaric bupivacaine; 12.5 mg of hyperbaric bupivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty
Experimental: Isobaric ropivacaine; 15 mg of 0.5% isobaric ropivacaine	Drug: Isobaric ropivacaine; 15 mg of isobaric ropivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mohamed Sayed Mohamed Abbas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: MSAT-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes