AnesthesiaPhase 4NCT01548794
Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy
A Phase 4 study testing spinal anesthesia and infiltration anesthesia in people with Anesthesia and Inguinal Hernia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Anesthesia, Inguinal Hernia
- What is being tested?
- spinal anesthesia and infiltration anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Jun 2012
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having inguinal hernia
- Not hypersensitive to study drugs
- ASA classification I-III
Who cannot join
- ASA classification IV-V
- Contraindications for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06610
About this study
Official title: A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy
The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.
Read the detailed description
Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.
- Conditions
- Anesthesia, Inguinal Hernia
- Being tested
- spinal anesthesia, infiltration anesthesia
- Keywords
- spinal anesthesia, bupivacaine, lidocaine, local infiltration anesthesia, recovery, duration of anesthesia, outpatient herniorrhaphy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
Also called marcaine heavy
To receive 2 ml heavy bupivacaine + 0,6 ml saline
spinal anesthesiaProcedure or surgery
Also called marcaine heavy, lidocaine
To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
infiltration anesthesiaProcedure or surgery
Also called marcaine, lidocaine
To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine(Group B) | Active comparator | spinal anesthesia Receives: Procedure: spinal anesthesia |
| Bupivacaine+Lidocaine (Group BL) | Experimental | spinal anesthesia Receives: Procedure: spinal anesthesia |
| Local Infitration Anesthesia(Group LI) | Active comparator | local infiltration anesthesia Receives: Procedure: infiltration anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of spinal block
Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.
Measured: day of surgery
Secondary outcomes (1)
Discharge time
The time between the end of surgery and home discharge.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek Yazicioglu, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548794
- Sponsor's protocol ID
- DiskapiTRHDYAZICIOGLU
- Status last verified
- Dec 2012
- First submitted
- 6 Mar 2012
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.
PubMed 18713891
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy
- ClinicalTrials.gov ID
- NCT01548794
- Acronym / sponsor ID
- DiskapiTRHDYAZICIOGLU
- Conditions
- Anesthesia, Inguinal Hernia
- Keywords
- spinal anesthesia, bupivacaine, lidocaine, local infiltration anesthesia, recovery, duration of anesthesia, outpatient herniorrhaphy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Mar 2012 (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.
The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.
Detailed description
Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine(Group B) | Active comparator | Procedure: spinal anesthesiaspinal anesthesia |
| Bupivacaine+Lidocaine (Group BL) | Experimental | Procedure: spinal anesthesiaspinal anesthesia |
| Local Infitration Anesthesia(Group LI) | Active comparator | Procedure: infiltration anesthesialocal infiltration anesthesia |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients having inguinal hernia
- Not hypersensitive to study drugs
- ASA classification I-III
Key exclusion criteria (2 listed)
- ASA classification IV-V
- Contraindications for spinal anesthesia
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 |
|---|---|---|
| spinal anesthesiaAlso: marcaine heavyTo receive 2 ml heavy bupivacaine + 0,6 ml saline | Procedure or surgery | Bupivacaine(Group B) |
| spinal anesthesiaAlso: marcaine heavy, lidocaineTo receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia. | Procedure or surgery | Bupivacaine+Lidocaine (Group BL) |
| infiltration anesthesiaAlso: marcaine, lidocaineTo receive step by step local infiltration anesthesia as described by the Lichtenstein Institute. | Procedure or surgery | Local Infitration Anesthesia(Group LI) |
Primary outcome
Duration of spinal block
Time frame: day of surgery
Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.
1 secondary outcome
Discharge time
Time frame: Day of surgery
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 22 Apr 2015.
- Background: PubMed 18713891Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.
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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.
Dilek Yazicioglu principal investigator
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 spinal anesthesia and infiltration anesthesia in people with Anesthesia and Inguinal Hernia, 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 3 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 22 Apr 2015. 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?
Duration of spinal block (time frame: day of surgery). 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 NCT01548794, which also lists 1 linked publication.
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 22 Apr 2015.