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Trial #NCT01845389
Anesthesia; Adverse Effect, Spinal and Epidural Clinical Trials

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


Comparative Study Between Continuous Epidural Anesthesia Using Standard Epidural Catheter And Continuous Spinal Anesthesia Using Wiley™ Spinal Catheter In Geriatric Patients Undergoing TURP
Study ID: Anesth-2013; Source: Theodor Bilharz Research Institute
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
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Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country Egypt
Study type Interventional
Enrollment 30
Start date March 2012
Completion date January 2014
Phase N/A
Sponsor Theodor Bilharz Research Institute
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
Description:
Geriatric patients have a significantly higher incidence of morbidity and morality during
surgery compared with younger age group as they commonly have respiratory, circulatory and
renal problems [1]. Transurethral resection of the prostate (TURP) is the gold standard
treatment for elderly patients with bladder outlet obstruction. TURP procedure has been
associated with high morbidity rate including bleeding, TURP syndrome, bladder perforation,
hypothermia and disseminated intravascular coagulation during intraoperative and early
postoperative period. Therefore, it becomes very important to keep a stable anesthesia that
minimizes these side effects. Detection of such complications is quite difficult under
general anesthesia as compared to regional anesthesia. Thus Regional techniques may be
better tolerated in the elderly patients undergoing TURP having the advantages of minimizing
blood loss and thromboembolic events [2].

Subarachnoid single dose injection provides a potent blockade of fast onset while its
extension and duration are difficult to predict [3]. Continuous epidural anesthesia with a
catheter placement offers flexibility to extend, intensify, and maintain the block as well
as providing postoperative analgesia [4]. Continuous spinal anesthesia consists of
introducing a catheter in the subarachnoid space and maintaining blockade by repeated
anesthetic injections. The possibility of fractionating local anesthetics dosage along time
allows a fast onset with better blockade quality and less hemodynamic changes [5]. Recent
study [6] reported that pain scores in patients received continuous spinal anesthesia were
significantly lower than those received continuous femoral nerve block.

Advantages of continuous spinal anesthesia include the following: (a) Prior placement of the
catheter in the induction area facilitates the surgical schedule. (b) Spinal anesthesia may
be induced through the catheter after the patient has been positioned for surgery, thereby
lessening the potential for hypotension. (c) The low doses of local anesthetic
intermittently injected eliminate the possibility of systemic toxic reactions. (d) Repeated
injection of small doses of local anesthetic solution facilitates obtaining the right level
of anesthesia and decreases the cardiovascular instability during induction. (e) Employing a
low dose of local anesthetic shortens the recovery period. (f) Anesthesia can be prolonged
when the duration of surgery is uncertain. (g) A definite end point (aspiration of
cerebrospinal fluid) assures that the catheter is in the right place and so enhances the
likelihood of successful anesthesia. (h) Subarachnoid narcotics may be administered during a
surgical procedure or continued into the recovery period to provide long-lasting
postoperative analgesia [7].

The disadvantages of continuous spinal anesthesia are as follows: (a) Additional time is
required to place the catheter in the right place, which may occasionally prove difficult.
(b) Spinal headache is possible. (c) There is a potential for catheter breakage, infection,
nerve trauma, and hemorrhage (these potential complications have, however, rarely been
documented in previous clinical settings). The primary factor that has limited use of
continuous spinal anesthesia is the belief that the large size of available spinal catheters
requiring insertion through large spinal needles will result in an incidence of post dural
puncture headache (PDPH) in young patients that is unacceptable [7].

The Wiley Spinal™ (Epimed; Johnstown, NY) catheter is an innovative flexible cannula over
needle designed for convenient intrathecal access that reduces PDPH [8]. 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. The primary outcome of this
study is the hemodynamic variability between both techniques. Secondary outcomes of interest
are detection of adverse events including early and late neurological complications. Thus
the aim of this prospective randomized study is to compare the efficacy of the continuous
spinal anesthesia using the Wiley spinal catheter and continuous epidural anesthesia in
geriatric patients undergoing TURP.
Eligibility:
Gender: Male
Age: 60 Years - N/A
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
Outcome:
Primary outcome
  • Systolic blood pressure
    Non- invasive blood pressure, heart rate and pulse oximetry 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.
    Time frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes
Secondary outcome
  • detection of adverse events
    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)
    Time frame: 30 days
Contacts:
  • Reeham S Ebeid, MD; Theodor Bilharz Research Institute (Principal Investigator)
Location Country Status
Kasr El Aini University Hospital Cairo, Egypt
Theodor Bilharz Research Institute Giza, Egypt
Sponsors:
  • Theodor Bilharz Research Institute - (Lead Sponsor)
  • Cairo University - Collaborator

Related trials: References:
  • Krämer S, Wenk M, Fischer G, Möllmann M, Pöpping 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. PubMed PMID: 21483383.
  • 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.
  • 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. Review.
  • 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.
Terms
  • Wiley Catheter
  • Regional
  • Anesthesia
  • TURP
  • Geriatric
  • Epidural
  • Continuous spinal
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