NCT01845389

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

April 26, 2013

Last Update Submit

March 9, 2016

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Keywords

AnesthesiaRegionalEpiduralContinuous spinalWiley CatheterGeriatricTURP

Outcome Measures

Primary Outcomes (1)

  • Mean arterial blood pressure

    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.

    Participants will be followed for the duration of surgery, an expected average of 90 minutes

Secondary Outcomes (5)

  • Heart rate

    Participants will be followed for the duration of surgery, an expected average of 90 minutes

  • detection of adverse events

    30 days

  • Characteristics of sensory block

    Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)

  • Characteristics of motor block

    Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)

  • Time to first analgesic injection

    Every hour postoperatively up to 10 hours.

Study Arms (2)

Epidural

EXPERIMENTAL

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)

Spinal

ACTIVE COMPARATOR

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)

Interventions

Epidural (B. Braun)DEVICE

20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air.

Also known as: B. Braun
Epidural
Spinal (Wiley Spinal Catheter)DEVICE

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.

Also known as: Wiley Spinal Catheter
Spinal

Eligibility Criteria

Age60 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kasr El Aini University Hospital

Cairo, Egypt

Location

Theodor Bilharz Research Institute

Giza, 12511, Egypt

Location

Related Publications (4)

  • Kramer S, Wenk M, Fischer G, Mollmann M, Popping DM. Continuous spinal anesthesia versus continuous femoral nerve block for elective total knee replacement. Minerva Anestesiol. 2011 Apr;77(4):394-400. Epub 2011 Feb 1.

    PMID: 21483383BACKGROUND

  • Ozmen S, Kosar A, Soyupek S, Armagan A, Hoscan MB, Aydin C. The selection of the regional anaesthesia in the transurethral resection of the prostate (TURP) operation. Int Urol Nephrol. 2003;35(4):507-12. doi: 10.1023/b:urol.0000025616.21293.6c.

    PMID: 15198156BACKGROUND

  • Palmer CM. Continuous spinal anesthesia and analgesia in obstetrics. Anesth Analg. 2010 Dec;111(6):1476-9. doi: 10.1213/ANE.0b013e3181f7e3f4. Epub 2010 Oct 1.

    PMID: 20889935BACKGROUND

  • Tao W, Nguyen AP, Ogunnaike BO, Craig MG. Use of a 23-gauge continuous spinal catheter for labor analgesia: a case series. Int J Obstet Anesth. 2011 Oct;20(4):351-4. doi: 10.1016/j.ijoa.2011.07.010. Epub 2011 Sep 9.

    PMID: 21907561BACKGROUND

Related Links

MeSH Terms

Interventions

Injections, Epidural

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Reeham S Ebeid, MD

    Theodor Bilharz Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 3, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)