AnesthesiaNCT01157247
Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
A study testing Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture in people with Anesthesia and Spinal Puncture, run by Croatian Society of Regional Anesthesia and Analgesia at 1 site in Croatia.
Trial summary
Background and Objectives: Spinal puncture is painful procedure which may cause patient refusal of spinal anesthesia in future surgery. It could be minimized with topical and infiltration local anesthetic or intravenous opioid application before procedure. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Anesthesia, Spinal Puncture
- What is being tested?
- Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCroatia
- Study dates
- Apr 2009to Jul 2010
- 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults
- ASA I or II status
- Scheduled for trauma or orthopedic surgeries of lower leg in spinal anesthesia
Who cannot join
- Patients with scoliosis
- Degenerative spine deformity
- A history of back surgery or back pain
- Pregnancy
- Perence of coagulopathy
- Systemic or local infection
Show all 11Show fewer
- Allergy to amide-local anesthetics
- Neurologic damages and mental disability
- More than one spinal puncture attempt
- Patient who was unable to estimate pain score
- High Ramsay sedation score
Trial locations and contacts
1 site in 1 country.
About this study
Background and Objectives: Spinal puncture is painful procedure which may cause patient refusal of spinal anesthesia in future surgery. It could be minimized with topical and infiltration local anesthetic or intravenous opioid application before procedure. Objective was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion.
Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled for lower leg surgery. Patients were divided in four equal study groups: spinal needle (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic infiltration (2 ml of 2% lidocaine, 25Gx11/4" needle) or intravenous fentanyl application (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.
- Conditions
- Anesthesia, Spinal Puncture
- Being tested
- Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
- Keywords
- Anesthetic techniques, regional, spinal, Pain, lumbar puncture, Analgesia, local, Analgesia, intravenous
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle punctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group SNI | Other | Insertion of spinal needle with introducer Receives: Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture |
| Group SNI+LA | Other | Local infiltration of lidocaine was applied three minutes after insertion of spinal needle with introducer Receives: Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture |
| Group SNI+F | Other | Intravenous fentanyl was applied 3 min before insertion of spinal needle with introducer Receives: Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture |
| Group SN | Other | Spinal puncture was performed only with spinal needle without introducer, local anesthetic infiltration or intravenous fentanyl before spinal puncture. Receives: Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJul 2010
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 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croatian Society of Regional Anesthesia and Analgesia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157247
- Sponsor's protocol ID
- CSRAA-CMA:007/03
- Status last verified
- Jun 2010
- First submitted
- 6 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Almeida GP, Boos GL, Alencar TG, Oliveira Filho GR. [Onset of 1% lidocaine for skin infiltrative anesthesia]. Rev Bras Anestesiol. 2005 Jun;55(3):284-8. doi: 10.1590/s0034-70942005000300005. Portuguese.
PubMed 19471833Kaur G, Gupta P, Kumar A. A randomized trial of eutectic mixture of local anesthetics during lumbar puncture in newborns. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1065-70. doi: 10.1001/archpedi.157.11.1065.
PubMed 14609894Calderon E, Pernia A, Roman MD, Perez AC, Torres LM. [Analgesia and sedation in the subarachnoid anesthesia technique: comparative study between remifentanil and fentanyl/midazolam]. Rev Esp Anestesiol Reanim. 2003 Mar;50(3):121-5. Spanish.
PubMed 12708207
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
- ClinicalTrials.gov ID
- NCT01157247
- Acronym / sponsor ID
- CSRAA-CMA:007/03
- Conditions
- Anesthesia, Spinal Puncture
- Keywords
- Anesthetic techniques, regional, spinal, Pain, lumbar puncture, Analgesia, local, Analgesia, intravenous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Croatian Society of Regional Anesthesia and AnalgesiaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Jul 2010 (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.
Background and Objectives: Spinal puncture is painful procedure which may cause patient refusal of spinal anesthesia in future surgery. It could be minimized with topical and infiltration local anesthetic or intravenous opioid application before procedure. Objective was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion.
Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled for lower leg surgery. Patients were divided in four equal study groups: spinal needle (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic infiltration (2 ml of 2% lidocaine, 25Gx11/4" needle) or intravenous fentanyl application (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.
Study design
- Primary purpose
- Treatment
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group SNI | Other | Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle punctureInsertion of spinal needle with introducer |
| Group SNI+LA | Other | Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle punctureLocal infiltration of lidocaine was applied three minutes after insertion of spinal needle with introducer |
| Group SNI+F | Other | Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle punctureIntravenous fentanyl was applied 3 min before insertion of spinal needle with introducer |
| Group SN | Other | Procedure: Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle punctureSpinal puncture was performed only with spinal needle without introducer, local anesthetic infiltration or intravenous fentanyl before spinal puncture. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults
- ASA I or II status
- Scheduled for trauma or orthopedic surgeries of lower leg in spinal anesthesia
Key exclusion criteria (11 listed)
- Patients with scoliosis
- Degenerative spine deformity
- A history of back surgery or back pain
- Pregnancy
- Perence of 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 |
|---|---|---|
| Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture | Procedure or surgery | Group SN, Group SNI, Group SNI+F, Group SNI+LA |
Primary outcome
Not reported in the source record.
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 7 Jul 2010.
- Results publication: PubMed 19471833Almeida GP, Boos GL, Alencar TG, Oliveira Filho GR. [Onset of 1% lidocaine for skin infiltrative anesthesia]. Rev Bras Anestesiol. 2005 Jun;55(3):284-8. doi: 10.1590/s0034-70942005000300005. Portuguese.
- Results publication: PubMed 14609894Kaur G, Gupta P, Kumar A. A randomized trial of eutectic mixture of local anesthetics during lumbar puncture in newborns. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1065-70. doi: 10.1001/archpedi.157.11.1065.
- Results publication: PubMed 12708207Calderon E, Pernia A, Roman MD, Perez AC, Torres LM. [Analgesia and sedation in the subarachnoid anesthesia technique: comparative study between remifentanil and fentanyl/midazolam]. Rev Esp Anestesiol Reanim. 2003 Mar;50(3):121-5. Spanish.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture in people with Anesthesia and Spinal Puncture, run by Croatian Society of Regional Anesthesia and Analgesia at 1 site in Croatia.
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 11 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 7 Jul 2010. 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 Croatia. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157247, 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 7 Jul 2010.