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

Anesthesia; Adverse Effect, Spinal and Epidural Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845389
• Other study ID #: Anesth-2013
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: March 9, 2016
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2016
• Source: Theodor Bilharz Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review BoardEgypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect, Spinal and Epidural

Intervention

Device:
• Epidural (B. Braun)
20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air.
• 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.

Locations

Country	Name	City	State
Egypt	Kasr El Aini University Hospital	Cairo
Egypt	Theodor Bilharz Research Institute	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Theodor Bilharz Research Institute	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Heart rate	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.	Participants will be followed for the duration of surgery, an expected average of 90 minutes	Yes
Secondary	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)	30 days	Yes
Secondary	Characteristics of sensory block	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.	Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)	Yes
Secondary	Characteristics of motor block	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.	Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)	Yes
Secondary	Time to first analgesic injection	0-10 visual analogue scale (VAS) (0: no pain at all, 10: maximum imaginable pain).	Every hour postoperatively up to 10 hours.	Yes