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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764723
• Other study ID #: MSAT-3
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: June 6, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Al Mouwasat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia
• Total Knee Arthroplasty in Geriatric Patients

Intervention

Drug:
• Hyperbaric bupivacaine
12.5 mg of hyperbaric bupivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty
• Isobaric ropivacaine
15 mg of isobaric ropivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Mohamed Abbas

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Respiratory depression	Respiratory depression (defined as respiratory rate < 8 min and SPO 2 < 90%)	within 2 years	Yes