Comparative Study Between Continuous Epidural Anesthesia And Continuous Spinal Anesthesia Using Wiley™ Spinal Catheter

This study has been completed.
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Yasser Mostafa Samhan, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier:
NCT01845389
First received: April 26, 2013
Last updated: March 9, 2016
Last verified: March 2016
  Purpose
Geriatric patients have a significantly higher incidence of morbidity and morality during surgery compared with younger age group. Transurethral resection of the prostate (TURP) is the gold standard treatment for elderly patients with bladder outlet obstruction. Thus Regional techniques may be better tolerated in the elderly patients undergoing TURP having the advantages of minimizing blood loss and thromboembolic events. The Wiley Spinal™ (Epimed; Johnstown, NY) catheter is an innovative flexible cannula over needle designed for convenient intrathecal access that reduces PDPH. We hypothesized that using less anesthetics during continuous spinal anesthesia with the Wiley spinal catheter would offer more hemodynamic stability with less side effects when compared with continuous epidural anesthesia in patients undergoing TURP

Condition Intervention
Anesthesia; Adverse Effect, Spinal and Epidural
Device: Epidural (B. Braun)
Device: Spinal (Wiley Spinal Catheter)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Study Between Continuous Epidural Anesthesia Using Standard Epidural Catheter And Continuous Spinal Anesthesia Using Wiley™ Spinal Catheter In Geriatric Patients Undergoing TURP

Further study details as provided by Theodor Bilharz Research Institute:

Primary Outcome Measures:
  • Mean arterial blood pressure [ Time Frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes ] [ Designated as safety issue: Yes ]
    Non- invasive blood pressure will be recorded before administering anesthesia, immediately after placing the catheter, every 1min for the first 10 min, then every 5 min till end of the operation.


Secondary Outcome Measures:
  • Heart rate [ Time Frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes ] [ Designated as safety issue: Yes ]
    Heart rate will be recorded before administering anesthesia, immediately after placing the catheter, every 1min for the first 10 min, then every 5 min till end of the operation.

  • detection of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    failure of regional anesthesia (unilateral or patchy block), pruritus, dizziness, nausea, vomiting, itching, PDPH and symptoms suggestive of neurologic damage (back pain, numbness, weakness or pain in legs, and bladder or bowel dysfunction)

  • Characteristics of sensory block [ Time Frame: Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively) ] [ Designated as safety issue: Yes ]
    A pinprick test is recorded 2 minutes after local anesthetic injection the every 2 minutes for the first 15 minutes then every 10 minutes till the end of operation then every 30 minutes until resolution of the block.

  • Characteristics of motor block [ Time Frame: Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively) ] [ Designated as safety issue: Yes ]
    Modified Bromage scale is recorded 2 minutes after local anesthetic injection the every 2 minutes for the first 15 minutes then every 10 minutes till the end of operation then every 30 minutes until resolution of the block.

  • Time to first analgesic injection [ Time Frame: Every hour postoperatively up to 10 hours. ] [ Designated as safety issue: Yes ]
    0-10 visual analogue scale (VAS) (0: no pain at all, 10: maximum imaginable pain).


Enrollment: 30
Study Start Date: June 2013
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epidural
epidural anesthesia was administered via a 20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air. Bupivacaine 0.5% 5 ml every 5 minutes for T10 sensory level
Device: Epidural (B. Braun)
20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air.
Other Name: B. Braun
Active Comparator: Spinal
An18-gauge Tuohy peel-away epidural sheath was introduced into the epidural space by using loss of resistance technique to air. Epidural introducer was removed leaving epidural sheath to be a pathway for Wiley spinal catheter. A flexible, convenience curve 27-gauge atraumatic pencil point tip spinal needle was introduced through the epidural sheath. After CSF flow was confirmed, a 23-gauge flexible cannula was threaded over the spinal needle. Peel-away epidural sheath was removed and flexible cannula was continually advanced over the spinal needle into the intrathecal space cephaled. Bupivacaine 0.5% 0.5 ml every 5 minutes for T10 sensory level.
Device: Spinal (Wiley Spinal Catheter)
The Wiley Spinal® is an innovative Flexible Cannula over Needle designed for convenient intrathecal access. After dural puncture is achieved, an immediate dural seal is created. The flexible cannula is advanced off the needle ensuring cephalad delivery of medication.
Other Name: Wiley Spinal Catheter

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I, II or III
  • geriatric male patients
  • aged over 60 years
  • scheduled for elective TURP under regional anesthesia

Exclusion Criteria:

  • neurological diseases
  • mental disturbance
  • previous history of stroke
  • severe cardiopulmonary disorders
  • clinically significant coagulopathy
  • lumbar disc herniation
  • previous back surgery
  • infection at the injection site
  • body mass index greater than 35 kg/m2
  • hypersensitivity to amide local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845389

Locations
Egypt
Kasr El Aini University Hospital
Cairo, Egypt
Theodor Bilharz Research Institute
Giza, Egypt, 12511
Sponsors and Collaborators
Theodor Bilharz Research Institute
Cairo University
Investigators
Principal Investigator: Reeham S Ebeid, MD Theodor Bilharz Research Institute
  More Information

Publications:
Responsible Party: Yasser Mostafa Samhan, Prof Dr, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT01845389     History of Changes
Other Study ID Numbers: Anesth-2013 
Study First Received: April 26, 2013
Last Updated: March 9, 2016
Health Authority: Egypt: Institutional Review Board
Egypt: Ministry of Higher Education
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Theodor Bilharz Research Institute:
Anesthesia
Regional
Epidural
Continuous spinal
Wiley Catheter
Geriatric
TURP

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2016