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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02764723
Enrollment
52
Registered
2016-05-06
Start date
2013-01-31
Completion date
2015-12-31
Last updated
2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Total Knee Arthroplasty in Geriatric Patients

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.

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.

Interventions

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

DRUGIsobaric ropivacaine

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

Sponsors

Mohamed Sayed Mohamed Abbas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the extent and duration of sensory blockwithin 2 yearsThe 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.
Changes in the extent and duration of motor blockwithin 2 yearsMotor 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.
Changes in the heart ratewithin 2 yearsAll 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.
Changes in the non invasive mean arterial blood pressurewithin 2 yearsAll 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.
Respiratory depressionwithin 2 yearsRespiratory depression (defined as respiratory rate \< 8 min and SPO 2 \< 90%)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026