Posterior Fossa TumorsPhase 2NCT02852382
The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery
A Phase 2 study testing Bupivacaine in people with Posterior Fossa Tumors, run by Istanbul University.
Trial summary
This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Posterior Fossa Tumors
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Dec 2016
- Phase
- Phase 2
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Posterior fossa surgery
- Preoperative GlasGow Coma Score: 15/15
Who cannot join
- Allergy to bupivacaine
- Uncontrolled hypertension
- Coagulopathy
- Cerebrovascular disease
- Earlier craniotomy
About this study
Official title: The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery
Read the detailed description
In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.
- Conditions
- Posterior Fossa Tumors
- Being tested
- Bupivacaine, morphine patient controlled analgesia
- Keywords
- scalp block, local infiltration
- Medical subject headings
- Infratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
morphine patient controlled analgesiaDrug
Also called MORPHİNE PCA
End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| scalp block | Active comparator | In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine. Receives: Drug: Bupivacaine; Drug: morphine patient controlled analgesia |
| local infiltration | Active comparator | In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area. Receives: Drug: Bupivacaine; Drug: morphine patient controlled analgesia |
| control | Placebo comparator | In this arm, neither scalp block, nor local infiltration will be performed. Receives: Drug: morphine patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate response to head pin replacement and skin incision
heart rates (beats per minute) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Measured: Intraoperative
Systolic arterial pressure response to head pin replacement and skin incision
Systolic arterial pressures (mmHg) will be recorded in before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Measured: Intraoperative
Diastolic arterial pressure response to head pin replacement and skin incision
Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Measured: Intraoperative
mean arterial pressure response to head pin replacement and skin incision
Mean arterial pressures (mmHg) will be recorded in will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Measured: Intraoperative
Secondary outcomes (2)
postoperative pain
pain scores (visual analogue score=VAS) will be evaluated.
Measured: 30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS)
morphine consumption
morphine dosage used (mg) will be recorded in this time periods
Measured: 30. minute, 1.,2.,6.,12.,24. hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Posterior Fossa TumorsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Fatma Akcil, Istanbul University
- Investigators
- Yusuf Tunali, Professor, Study director, Istanbul University Cerrahpasa Medical Faculty Department Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852382
- Sponsor's protocol ID
- Cerrahpasa Neuro
- Status last verified
- Aug 2017
- First submitted
- 26 Jul 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2.
PubMed 19262392Hansen MS, Brennum J, Moltke FB, Dahl JB. Pain treatment after craniotomy: where is the (procedure-specific) evidence? A qualitative systematic review. Eur J Anaesthesiol. 2011 Dec;28(12):821-9. doi: 10.1097/EJA.0b013e32834a0255.
PubMed 21971206Verchere E, Grenier B, Mesli A, Siao D, Sesay M, Maurette P. Postoperative pain management after supratentorial craniotomy. J Neurosurg Anesthesiol. 2002 Apr;14(2):96-101. doi: 10.1097/00008506-200204000-00002.
PubMed 11907388Jellish WS, Leonetti JP, Sawicki K, Anderson D, Origitano TC. Morphine/ondansetron PCA for postoperative pain, nausea, and vomiting after skull base surgery. Otolaryngol Head Neck Surg. 2006 Aug;135(2):175-81. doi: 10.1016/j.otohns.2006.02.027.
PubMed 16890064Irefin SA, Schubert A, Bloomfield EL, DeBoer GE, Mascha EJ, Ebrahim ZY. The effect of craniotomy location on postoperative pain and nausea. J Anesth. 2003;17(4):227-31. doi: 10.1007/s00540-003-0182-8.
PubMed 14625709Schessel DA, Nedzelski JM, Rowed D, Feghali JG. Pain after surgery for acoustic neuroma. Otolaryngol Head Neck Surg. 1992 Sep;107(3):424-9. doi: 10.1177/019459989210700314.
PubMed 1408229
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in
- ClinicalTrials.gov ID
- NCT02852382
- Acronym / sponsor ID
- Cerrahpasa Neuro
- Conditions
- Posterior Fossa Tumors
- Keywords
- scalp block, local infiltration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Aug 2016 (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.
This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery
Detailed description
In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| scalp block | Active comparator | Drug: Bupivacaine, Drug: morphine patient controlled analgesiaIn this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine. |
| local infiltration | Active comparator | Drug: Bupivacaine, Drug: morphine patient controlled analgesiaIn this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area. |
| control | Placebo comparator | Drug: morphine patient controlled analgesiaIn this arm, neither scalp block, nor local infiltration will be performed. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Posterior fossa surgery
- Preoperative GlasGow Coma Score: 15/15
Key exclusion criteria (5 listed)
- Allergy to bupivacaine
- Uncontrolled hypertension
- Coagulopathy
- Cerebrovascular disease
- Earlier craniotomy
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 |
|---|---|---|
| BupivacaineAlso: MarcaineIn the scalp block and local infiltration arms; bupivacaine %0,5 will be used. | Drug | local infiltration, scalp block |
| morphine patient controlled analgesiaAlso: MORPHİNE PCAEnd of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours. | Drug | control, local infiltration, scalp block |
Primary outcome
Heart rate response to head pin replacement and skin incision
Time frame: Intraoperative
heart rates (beats per minute) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Systolic arterial pressure response to head pin replacement and skin incision
Time frame: Intraoperative
Systolic arterial pressures (mmHg) will be recorded in before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
Diastolic arterial pressure response to head pin replacement and skin incision
Time frame: Intraoperative
Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
mean arterial pressure response to head pin replacement and skin incision
Time frame: Intraoperative
Mean arterial pressures (mmHg) will be recorded in will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision
2 secondary outcomes
postoperative pain
Time frame: 30. minute, 1.,2.,6.,12.,24. hours pain scores (visual analogue score=VAS)
morphine consumption
Time frame: 30. minute, 1.,2.,6.,12.,24. 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 22 Aug 2017.
- Results publication: PubMed 19262392Geze S, Yilmaz AA, Tuzuner F. The effect of scalp block and local infiltration on the haemodynamic and stress response to skull-pin placement for craniotomy. Eur J Anaesthesiol. 2009 Apr;26(4):298-303. doi: 10.1097/EJA.0b013e32831aedb2.
- Results publication: PubMed 21971206Hansen MS, Brennum J, Moltke FB, Dahl JB. Pain treatment after craniotomy: where is the (procedure-specific) evidence? A qualitative systematic review. Eur J Anaesthesiol. 2011 Dec;28(12):821-9. doi: 10.1097/EJA.0b013e32834a0255.
- Results publication: PubMed 11907388Verchere E, Grenier B, Mesli A, Siao D, Sesay M, Maurette P. Postoperative pain management after supratentorial craniotomy. J Neurosurg Anesthesiol. 2002 Apr;14(2):96-101. doi: 10.1097/00008506-200204000-00002.
- Results publication: PubMed 16890064Jellish WS, Leonetti JP, Sawicki K, Anderson D, Origitano TC. Morphine/ondansetron PCA for postoperative pain, nausea, and vomiting after skull base surgery. Otolaryngol Head Neck Surg. 2006 Aug;135(2):175-81. doi: 10.1016/j.otohns.2006.02.027.
- Results publication: PubMed 14625709Irefin SA, Schubert A, Bloomfield EL, DeBoer GE, Mascha EJ, Ebrahim ZY. The effect of craniotomy location on postoperative pain and nausea. J Anesth. 2003;17(4):227-31. doi: 10.1007/s00540-003-0182-8.
- Results publication: PubMed 1408229Schessel DA, Nedzelski JM, Rowed D, Feghali JG. Pain after surgery for acoustic neuroma. Otolaryngol Head Neck Surg. 1992 Sep;107(3):424-9. doi: 10.1177/019459989210700314.
- Individual participant dataSharing planned: Undecided
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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.
Yusuf Tunali, Professor study director
Istanbul University Cerrahpasa Medical Faculty Department Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine in people with Posterior Fossa Tumors, run by Istanbul University.
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 2 inclusion and 5 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Heart rate response to head pin replacement and skin incision (time frame: Intraoperative). The study lists 4 primary outcomes in all. 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 NCT02852382, which also lists 6 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 22 Aug 2017.