Anesthesia; Adverse Effect, Spinal and EpiduralNCT01845389
Comparative Study Between Continuous Epidural Anesthesia And Continuous Spinal Anesthesia Using Wiley™ Spinal Catheter
A study testing Epidural (B. Braun) and Spinal (Wiley Spinal Catheter) in people with Anesthesia; Adverse Effect, Spinal and Epidural, run by Theodor Bilharz Research Institute at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural
- What is being tested?
- Epidural (B. Braun) and Spinal (Wiley Spinal Catheter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I, II or III
- geriatric male patients
- aged over 60 years
- scheduled for elective TURP under regional anesthesia
Who cannot join
- neurological diseases
- mental disturbance
- previous history of stroke
- severe cardiopulmonary disorders
- clinically significant coagulopathy
- lumbar disc herniation
Show all 10Show fewer
- previous back surgery
- infection at the injection site
- body mass index greater than 35 kg/m2
- hypersensitivity to amide local anesthetics
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kasr El Aini University Hospital
Cairo
Theodor Bilharz Research Institute
Giza, 12511
About this study
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
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
Read the detailed 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.
- Being tested
- Epidural (B. Braun), Spinal (Wiley Spinal Catheter)
- Keywords
- Anesthesia, Regional, Epidural, Continuous spinal, Wiley Catheter, Geriatric, TURP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural (B. Braun)Device
Also called 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)Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Spinal (Wiley Spinal Catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of surgery, an expected average of 90 minutes
Secondary outcomes (5)
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.
Measured: Participants will be followed for the duration of surgery, an expected average of 90 minutes
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)
Measured: 30 days
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.
Measured: Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)
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.
Measured: Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)
Time to first analgesic injection
0-10 visual analogue scale (VAS) (0: no pain at all, 10: maximum imaginable pain).
Measured: Every hour postoperatively up to 10 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Yasser Mostafa Samhan, Theodor Bilharz Research Institute
- Investigators
- Reeham S Ebeid, MD, Principal investigator, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845389
- Sponsor's protocol ID
- Anesth-2013
- Status last verified
- Mar 2016
- First submitted
- 26 Apr 2013
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21483383Ozmen 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.
PubMed 15198156Palmer 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.
PubMed 20889935Tao 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.
PubMed 21907561
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01845389
- Acronym / sponsor ID
- Anesth-2013
- Keywords
- Anesthesia, Regional, Epidural, Continuous spinal, Wiley Catheter, Geriatric, TURP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | Experimental | Device: Epidural (B. Braun)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 |
| Spinal | Active comparator | Device: Spinal (Wiley Spinal Catheter)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists physical status I, II or III
- geriatric male patients
- aged over 60 years
- scheduled for elective TURP under regional anesthesia
Key exclusion criteria (10 listed)
- neurological diseases
- mental disturbance
- previous history of stroke
- severe cardiopulmonary disorders
- clinically significant coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural (B. Braun)Also: B. Braun20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air. | Device | Epidural |
| Spinal (Wiley Spinal Catheter)Also: Wiley Spinal CatheterThe 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. | Device | Spinal |
Primary outcome
Mean arterial blood pressure
Time frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes
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.
5 secondary outcomes
Heart rate
Time frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes
detection of adverse events
Time frame: 30 days
Characteristics of sensory block
Time frame: Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)
Characteristics of motor block
Time frame: Two minutes after injection of local anesthetic until resolution of the block (about 6 hours postoperatively)
Time to first analgesic injection
Time frame: Every hour postoperatively up to 10 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Background: PubMed 21483383Kramer 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.
- Background: PubMed 15198156Ozmen 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.
- Background: PubMed 20889935Palmer 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.
- Background: PubMed 21907561Tao 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.
- Home page of Theodor Bilharz Research InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reeham S Ebeid, MD principal investigator
Theodor Bilharz Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural (B. Braun) and Spinal (Wiley Spinal Catheter) in people with Anesthesia; Adverse Effect, Spinal and Epidural, run by Theodor Bilharz Research Institute at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (time frame: Participants will be followed for the duration of surgery, an expected average of 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01845389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016; AzTrials last refreshed its copy on 29 Oct 2026.