NCT01845389|Completed
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Sponsor study identifier
interventional
30
1 country
2
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
January 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2013
Actual (reported)May 3, 2013
Actual (reported)June 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 2013
Actual (reported)January 2014
Actual (reported)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
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.
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
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.
20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air.
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.
Kasr El Aini University Hospital
Cairo, Egypt
Theodor Bilharz Research Institute
Giza, 12511, Egypt
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.
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.
Reeham S Ebeid, MD
Theodor Bilharz Research Institute
30 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2013
First Posted
May 3, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
September 2013
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
March 10, 2016
Record last verified: 2016-03
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