HemorrhoidPhase 4NCT01880775
Discharge Conditions of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl
A Phase 4 study testing Prilocaine and Bupivacaine in people with Hemorrhoid and Peri Anal Fistula, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoid, Peri Anal Fistula
- What is being tested?
- Prilocaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2012to Jul 2013
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I-III
Who cannot join
- Patients with contraindications for spinal anesthesia,
- hypersensitivity to study drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: The Comparison of the Discharge Conditions and Efficacy of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl in Outpatient Minor Perianal Surgery
In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.
Read the detailed description
ASA status I-III patients will be recruited. Patients will be randomized in two groups. Group B will be received 1.5 ml heavy bupivacaine+ 20 mic fentanyl+ 0.15 ml and Group P will be received 1,5 ml heavy prilocaine+20 mic fentanyl in the same volume.Patients will be monitored with electrocardiography, peripheral oxygen saturation(sPO2) and non invasive blood pressure (Drager Infinity Delta; 16 Electronics Avenue, Danvers, MA 01923 USA). After inserting a 20 G intravenous line the patients will be hydrated with 10 ml/kg 0.9 % saline.
Preoperative systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR) and Spo2 will be measured and recorded.
Spinal anesthesia will be commenced in the sitting position with a 25 G Quincke needle, with the midline approach. After observing free flow of cerebrospinal fluid the prepared study drug will be injected in 15 seconds. The patients will be placed supine after waiting 2 minute in the sitting position. Supplemental oxygen via nasal cannula will be provided.
Fentanyl and midazolam will be used for rescue analgesia and sedation and recorded.
Sensorial block will be assessed with pinprick test with 2 minute intervals until the maximum block achieves and with 15 minute intervals until the block was regresses to S3 dermatome. Motor block will be assessed with the Bromage score when the block reached the maximum level. Patients will be transferred to postoperative care unit (PACU) at he end of surgery.
Pain will be assessed on a 10 point visual analog scale (VAS)(0= no pain, 10= worst pain ever). Postoperative analgesia will be provided with 2 mg.kg-1 tramadol or 15 mg.kg-1 paracetamol when the VAS score is ≥3 time of first analgesic request will be recorded.
Hypotension (≥20% reduced from baseline values) will be treated with ephedrine or iv fluid boluses), bradycardia (HR<45 beat min-1 was treated with atropine) was recorded.
The patients will be asked whether to void before surgery. Bladder volume will be assessed with ultrasonography. Patients with residual bladder volumes ≥400 ml will be placed an urine catheter. Time to first urinate will be recorded.
Patients will be assessed for transient neurologic symptoms(pain in the buttocks and legs)(TNS) and satisfaction after surgery.
TNS will be evaluated with daily telephone calls. Patient satisfaction will be evaluated with global satisfaction scale (1= bad, 2=not satisfied, 3=have no idea, 4=satisfied, 5=very satisfied) Parameters to record; time of entering operation room, duration of surgery, time of intrathecal injection, onset of sensorial block(block at L1), time to reach maximum block level, maximum block level, first analgesic ingestion time, PACU duration, two segment regression, time to L1 regression, time to S3 regression, time to it without help, time to stand up without help, time to walk without help, discharge time, time to first void. TNS, patient satisfaction score.
- Conditions
- Hemorrhoid, Peri Anal Fistula
- Being tested
- Prilocaine, Bupivacaine
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrilocaineDrug
Also called prilothecal, citanest
experimental
BupivacaineDrug
Also called marcaine heavy 0.5%
marcaine heavy 0.5% 7.5 mg intrathecal
| Study group | Role | What they receive |
|---|---|---|
| prilocaine heavy 2%& fentanyl | Experimental | prilocaine heavy 2% 30 mg and fentanyl 20 micgr ampoule intrathecal Receives: Drug: Prilocaine |
| bupivacaine heavy 0.5% & fentanyl | Active comparator | bupivacaine heavy 0.5% 7.5 mg and fentanyl 20 micg ampoule intrathecal Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block regression at S3 (time, minute)
spinal anesthesia
Measured: postoperative 30. minute
Secondary outcomes (1)
discharge time (minute)
spinal anesthesia
Measured: postoperative 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Gorgoz Kaban, Diskapi Teaching and Research Hospital
- Investigators
- Taylan Akkaya, Assoc Prof., Study director, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880775
- Sponsor's protocol ID
- OKabanPrilocain
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
PubMed 20529983Black AS, Newcombe GN, Plummer JL, McLeod DH, Martin DK. Spinal anaesthesia for ambulatory arthroscopic surgery of the knee: a comparison of low-dose prilocaine and fentanyl with bupivacaine and fentanyl. Br J Anaesth. 2011 Feb;106(2):183-8. doi: 10.1093/bja/aeq272. Epub 2010 Oct 14.
PubMed 20947591Ostgaard G, Hallaraker O, Ulveseth OK, Flaatten H. A randomised study of lidocaine and prilocaine for spinal anaesthesia. Acta Anaesthesiol Scand. 2000 Apr;44(4):436-40. doi: 10.1034/j.1399-6576.2000.440413.x.
PubMed 10757577
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Discharge Conditions and Efficacy of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl in Outpatient Minor Perianal Surgery
- ClinicalTrials.gov ID
- NCT01880775
- Acronym / sponsor ID
- OKabanPrilocain
- Conditions
- Hemorrhoid, Peri Anal Fistula
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Jun 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.
In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.
Detailed description
ASA status I-III patients will be recruited. Patients will be randomized in two groups. Group B will be received 1.5 ml heavy bupivacaine+ 20 mic fentanyl+ 0.15 ml and Group P will be received 1,5 ml heavy prilocaine+20 mic fentanyl in the same volume.Patients will be monitored with electrocardiography, peripheral oxygen saturation(sPO2) and non invasive blood pressure (Drager Infinity Delta; 16 Electronics Avenue, Danvers, MA 01923 USA). After inserting a 20 G intravenous line the patients will be hydrated with 10 ml/kg 0.9 % saline.
Preoperative systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR) and Spo2 will be measured and recorded.
Spinal anesthesia will be commenced in the sitting position with a 25 G Quincke needle, with the midline approach. After observing free flow of cerebrospinal fluid the prepared study drug will be injected in 15 seconds. The patients will be placed supine after waiting 2 minute in the sitting position. Supplemental oxygen via nasal cannula will be provided.
Fentanyl and midazolam will be used for rescue analgesia and sedation and recorded.
Sensorial block will be assessed with pinprick test with 2 minute intervals until the maximum block achieves and with 15 minute intervals until the block was regresses to S3 dermatome. Motor block will be assessed with the Bromage score when the block reached the maximum level. Patients will be transferred to postoperative care unit (PACU) at he end of surgery.
Pain will be assessed on a 10 point visual analog scale (VAS)(0= no pain, 10= worst pain ever). Postoperative analgesia will be provided with 2 mg.kg-1 tramadol or 15 mg.kg-1 paracetamol when the VAS score is ≥3 time of first analgesic request will be recorded.
Hypotension (≥20% reduced from baseline values) will be treated with ephedrine or iv fluid boluses), bradycardia (HR<45 beat min-1 was treated with atropine) was recorded.
The patients will be asked whether to void before surgery. Bladder volume will be assessed with ultrasonography. Patients with residual bladder volumes ≥400 ml will be placed an urine catheter. Time to first urinate will be recorded.
Patients will be assessed for transient neurologic symptoms(pain in the buttocks and legs)(TNS) and satisfaction after surgery.
TNS will be evaluated with daily telephone calls. Patient satisfaction will be evaluated with global satisfaction scale (1= bad, 2=not satisfied, 3=have no idea, 4=satisfied, 5=very satisfied) Parameters to record; time of entering operation room, duration of surgery, time of intrathecal injection, onset of sensorial block(block at L1), time to reach maximum block level, maximum block level, first analgesic ingestion time, PACU duration, two segment regression, time to L1 regression, time to S3 regression, time to it without help, time to stand up without help, time to walk without help, discharge time, time to first void. TNS, patient satisfaction score.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prilocaine heavy 2%& fentanyl | Experimental | Drug: Prilocaineprilocaine heavy 2% 30 mg and fentanyl 20 micgr ampoule intrathecal |
| bupivacaine heavy 0.5% & fentanyl | Active comparator | Drug: Bupivacainebupivacaine heavy 0.5% 7.5 mg and fentanyl 20 micg ampoule intrathecal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA status I-III
Key exclusion criteria (2 listed)
- Patients with contraindications for spinal anesthesia,
- hypersensitivity to study drugs
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 |
|---|---|---|
| PrilocaineAlso: prilothecal, citanestexperimental | Drug | prilocaine heavy 2%& fentanyl |
| BupivacaineAlso: marcaine heavy 0.5%marcaine heavy 0.5% 7.5 mg intrathecal | Drug | bupivacaine heavy 0.5% & fentanyl |
Primary outcome
Sensory block regression at S3 (time, minute)
Time frame: postoperative 30. minute
spinal anesthesia
1 secondary outcome
discharge time (minute)
Time frame: postoperative 2 hour
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 3 Jun 2014.
- Background: PubMed 20529983Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
- Background: PubMed 20947591Black AS, Newcombe GN, Plummer JL, McLeod DH, Martin DK. Spinal anaesthesia for ambulatory arthroscopic surgery of the knee: a comparison of low-dose prilocaine and fentanyl with bupivacaine and fentanyl. Br J Anaesth. 2011 Feb;106(2):183-8. doi: 10.1093/bja/aeq272. Epub 2010 Oct 14.
- Background: PubMed 10757577Ostgaard G, Hallaraker O, Ulveseth OK, Flaatten H. A randomised study of lidocaine and prilocaine for spinal anaesthesia. Acta Anaesthesiol Scand. 2000 Apr;44(4):436-40. doi: 10.1034/j.1399-6576.2000.440413.x.
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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.
Taylan Akkaya, Assoc Prof. study director
Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prilocaine and Bupivacaine in people with Hemorrhoid and Peri Anal Fistula, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sensory block regression at S3 (time, minute) (time frame: postoperative 30. minute). 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 NCT01880775, which also lists 3 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 3 Jun 2014.