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Completed

NCT Number: NCT02764723

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

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.

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Key information

Conditions

Total Knee Arthroplasty in Geriatric Patients Spinal Anesthesia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric bupivacaine

Drug

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

Isobaric ropivacaine

Drug

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

Primary outcomes

  1. Changes in the extent and duration of sensory block

    Time frame: within 2 years

    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.

  2. Changes in the extent and duration of motor block

    Time frame: within 2 years

    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.

  3. Changes in the heart rate

    Time frame: within 2 years

    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.

  4. Changes in the non invasive mean arterial blood pressure

    Time frame: within 2 years

    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.

  5. Respiratory depression

    Time frame: within 2 years

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

Sponsors and collaborators

Lead sponsor

Mohamed Sayed Mohamed Abbas

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 6, 2016
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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