Partial Scalp Block in Posterior Fossa Surgery
Primary Purpose
Posterior Fossa Tumor
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Partial scalp block
Fentanyl
Sponsored by
About this trial
This is an interventional prevention trial for Posterior Fossa Tumor focused on measuring Partial scalp block, Posterior fossa surgery, Greater occipital nerve, Lesser occipital nerve, Third occipital nerve, Fentanyl
Eligibility Criteria
Inclusion Criteria:
- Physical status ASA I and ASA ll.
- Males and females between the ages of 21 and 55.
- Patients undergoing posterior fossa Surgeries.
- Patients with GCS ≥14
- Patients undergoing operation in prone position
Exclusion Criteria:
- Patient refusal.
- Patients with a history of allergy to opioids or local anesthetics
- GCS (Glasgow coma score) ≤13 upon emergence from anesthesia.
- Patients who will need post-operative ventilation
- Patients who had previous craniotomies
- Patients with contraindication to regional anaesthesia e.g.: local sepsis,
- Patients with pre-existing peripheral neuropathies and coagulopathy.
- Patients who will develop intraoperative surgical complications
- Operations lasting more than 5 hours.
Sites / Locations
- Kasr El Aini Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Partial scalp block
Fentanyl group
Arm Description
Bilateral block of the greater lesser and third occipital nerves using bupivacaine 0.25% with epinephrine 1:200,000
Fentanyl infusion will be administered till time of dural closure
Outcomes
Primary Outcome Measures
Systolic blood pressure at time of skin incision
Recording of the systolic blood pressure in mmhg at the time of skin incision
Secondary Outcome Measures
Number of intraoperative fentanyl boluses
Total fentanyl boluses in micrograms which will be administered intraoperatively when heart rate and/or systolic arterial pressure values will exceed the baseline values by 25%
RASS score
Richmond agitation sedation score is a score used to describe the patients' level of alertness or agitation. It ranges from from -5 unarousable to +4 combative with 0 meaning alert and calm
Time for first rescue Analgesia
First time when the patient starts to complain of pain after surgery and an analgesic is given
Number of heart beats per minute (Heart rate)
Number of heart beats per minute
Systolic blood pressure
systolic blood pressure in mmhg
Mean arterial blood pressure
Mean arterial blood pressure in mmhg
Diastolic blood pressure
Diastolic blood pressure in mmhg
Intraoperative phentolamine consumption
the total amount of phentolamine in mg consumed intraoperatively
Intraoperative ephedrine consumption
the total amount of ephedrine in mg consumed intraoperatively
Time to extubation
It is the time between closure of inhalational anesthetic and extubation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955236
Brief Title
Partial Scalp Block in Posterior Fossa Surgery
Official Title
Partial Scalp Block Versus Fentanyl Infusion in Patients Undergoing Posterior Fossa Surgery Under General Anesthesia. A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Pain in patients undergoing posterior fossa surgery is regarded as more intense when compared to pain in patients undergoing supratentorial cranial surgeries. It may result in a rise in blood pressure and heart rate leading to serious effects as increased intracranial pressure and intracranial hemorrhage. For a long time, the control of pain has been the role of opioids. However, the use of opioids is not devoid of side effects. Hence, combining other techniques as partial scalp block with general anesthesia may be beneficial in controlling hemodynamics and decreasing the amount of opioids used without sacrificing the good quality of analgesia and anesthesia.
Detailed Description
Pain in patients undergoing posterior fossa surgery is regarded as more intense when compared to pain in patients undergoing supratentorial cranial surgeries. The main cause has been attributed to the substantial muscle dissection and trauma in this area.
Opioids remain as the current gold standard drugs for operative pain relief. However, exposure to large doses leads to multiple side effects of varying significance, such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and disorders of breathing during sleep. Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia.
Considering the previously mentioned facts, supplementing general anesthesia with regional anesthesia has been considered and was found to improve intraoperative hemodynamics, surgical field and postoperative analgesia.
In neurosurgery, scalp blocks and local anesthetic infiltration are being used along with general anesthesia either preoperatively to decrease the hemodynamic response to head pinning and surgical incision or postoperatively before emergence from anesthesia to decrease postoperative pain and result in a better outcome.
The current study aims to compare between partial scalp block(greater,lesser and third occipital nerve blocks) on the one hand versus fentanyl infusion on the other hand as pain controlling measures reflected on intraoperative hemodynamics in patients undergoing posterior fossa surgery.
After approval of ethics research committee and obtaining informed written consents from the patient's first degree relatives, 40 patients will be randomly divided by computer designed lists and then concealed in closed serially numbered, opaque envelopes into 2 equal groups to receive either partial scalp block(greater,lesser and third occipital nerve blocks) or fentanyl infusion after induction of general anesthesia by a conventional method and assuming the prone position.
For group N (partial nerve block group): The scalp blocks will be performed bilaterally after assuming the prone position by an anesthesiologist who will not be a part of the study team nor will be involved in the proceeding data analysis or other parts of the study. The Greater occipital will be blocked by injecting 3ml of local anaesthetic at a point half way between the mastoid process the external occipital protuberance along the superior nuchal line, medial to the occipital artery. The Lesser occipital nerve will be blocked by injecting 3ml of local anaesthetic infiltration along the superior nuchal line, 2.5 cm lateral to the greater occipital nerve block. The greater occipital nerve block will also cover the third occipital nerve due to the close location of the two nerves (8).
To anesthetize the dura Lidocaine soaked gauzes will be used and applied for 10 minutes before dural incision.
A placebo infusion (normal saline) was administered at the same rate as fentanyl infusion (1 µg/kg/hr.).
For group F ( Fentanyl group):1µg/kg/hr. of intravenous fentanyl infusion will be administered. A syringe filled with 20 ml of normal saline will be prepared and 3 ml of normal saline will be injected at the same points of the partial scalp block previously mentioned. Both the syringe containing bupivacaine and adrenaline and the placebo syringe will be prepared by a blinded clinical pharmacist, who will not be a part of the study team nor will be involved in the proceeding data analysis or other parts of the study.
The primary outcome will be the systolic blood pressure at time of skin incision. the sample size was calculated using the medcalc software. Based on the study "Bupivacaine scalp nerve block: Hemodynamic response during craniotomy, intraoperative and post-operative analgesia" published in Asian biomedicine (2010).
The total sample size required was 36 participants to be randomly allocated between two groups to achieve a confidence level of 95%, power of study 80% with confidence interval of 1. The sample size was increased to 40 (20 per group) to guard against dropouts.
SPSS software will be used for data analysis. Categorical data will be expressed as frequencies and percentages and will be analyzed using chi-square test. Continuous data will be tested for normality by means of shapiro-wilk test and will be analyzed using unpaired t test, Mann Whitney test, and analysis of variance test (ANOVA) as appropriate. The numerical data will be presented as mean and standard deviation or median and interquartile range as appropriate. A P value less than 0.05 will be considered significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Fossa Tumor
Keywords
Partial scalp block, Posterior fossa surgery, Greater occipital nerve, Lesser occipital nerve, Third occipital nerve, Fentanyl
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partial scalp block
Arm Type
Experimental
Arm Description
Bilateral block of the greater lesser and third occipital nerves using bupivacaine 0.25% with epinephrine 1:200,000
Arm Title
Fentanyl group
Arm Type
Active Comparator
Arm Description
Fentanyl infusion will be administered till time of dural closure
Intervention Type
Drug
Intervention Name(s)
Partial scalp block
Other Intervention Name(s)
N
Intervention Description
Partial scalp blocks will be performed bilaterally after assuming the prone position.The Greater occipital will be blocked by injecting 3ml of local anaesthetic at a point half way between the mastoid process the external occipital protuberance along the superior nuchal line, medial to the occipital artery. The Lesser occipital nerve will be blocked by injecting 3ml of local anaesthetic infiltration along the superior nuchal line, 2.5 cm lateral to the greater occipital nerve block. The greater occipital nerve block also will cover the third occipital nerve due to the close location of the two nerves.
A placebo infusion (normal saline) will be administered at the same rate as fentanyl infusion in the active comparator arm(1 µg/kg/hr.).
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
F
Intervention Description
1µg/kg/hr. of intravenous fentanyl infusion will be administered. A syringe filled with 20 ml of normal saline will be prepared and 3 ml of normal saline will be injected at the same points of the partial scalp block previously described
Primary Outcome Measure Information:
Title
Systolic blood pressure at time of skin incision
Description
Recording of the systolic blood pressure in mmhg at the time of skin incision
Time Frame
During surgery, 1 min after skin incision
Secondary Outcome Measure Information:
Title
Number of intraoperative fentanyl boluses
Description
Total fentanyl boluses in micrograms which will be administered intraoperatively when heart rate and/or systolic arterial pressure values will exceed the baseline values by 25%
Time Frame
During surgery
Title
RASS score
Description
Richmond agitation sedation score is a score used to describe the patients' level of alertness or agitation. It ranges from from -5 unarousable to +4 combative with 0 meaning alert and calm
Time Frame
One hour after the surgery
Title
Time for first rescue Analgesia
Description
First time when the patient starts to complain of pain after surgery and an analgesic is given
Time Frame
after the surgery
Title
Number of heart beats per minute (Heart rate)
Description
Number of heart beats per minute
Time Frame
baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after skin incision, 1min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.
Title
Systolic blood pressure
Description
systolic blood pressure in mmhg
Time Frame
baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure in mmhg
Time Frame
baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after skin incision, 1 min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.
Title
Diastolic blood pressure
Description
Diastolic blood pressure in mmhg
Time Frame
baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after skin incision, 1 min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.
Title
Intraoperative phentolamine consumption
Description
the total amount of phentolamine in mg consumed intraoperatively
Time Frame
throughout the operation
Title
Intraoperative ephedrine consumption
Description
the total amount of ephedrine in mg consumed intraoperatively
Time Frame
throughout the operation
Title
Time to extubation
Description
It is the time between closure of inhalational anesthetic and extubation
Time Frame
At the end of the operation, the time from the discontinuation of inhalation agents till extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physical status ASA I and ASA ll.
Males and females between the ages of 21 and 55.
Patients undergoing posterior fossa Surgeries.
Patients with GCS ≥14
Patients undergoing operation in prone position
Exclusion Criteria:
Patient refusal.
Patients with a history of allergy to opioids or local anesthetics
GCS (Glasgow coma score) ≤13 upon emergence from anesthesia.
Patients who will need post-operative ventilation
Patients who had previous craniotomies
Patients with contraindication to regional anaesthesia e.g.: local sepsis,
Patients with pre-existing peripheral neuropathies and coagulopathy.
Patients who will develop intraoperative surgical complications
Operations lasting more than 5 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania S Fahmy
Organizational Affiliation
Kasr Al Ainy, Faculty of medicine, Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr El Aini Hospital
City
Cairo
ZIP/Postal Code
11687
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26929661
Citation
Vadivelu N, Kai AM, Tran D, Kodumudi G, Legler A, Ayrian E. Options for perioperative pain management in neurosurgery. J Pain Res. 2016 Feb 10;9:37-47. doi: 10.2147/JPR.S85782. eCollection 2016.
Results Reference
background
PubMed Identifier
8942596
Citation
Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.
Results Reference
background
PubMed Identifier
24966149
Citation
Jian M, Li X, Wang A, Zhang L, Han R, Gelb AW. Flurbiprofen and hypertension but not hydroxyethyl starch are associated with post-craniotomy intracranial haematoma requiring surgery. Br J Anaesth. 2014 Nov;113(5):832-9. doi: 10.1093/bja/aeu185. Epub 2014 Jun 25.
Results Reference
background
PubMed Identifier
20479675
Citation
Osborn I, Sebeo J. "Scalp block" during craniotomy: a classic technique revisited. J Neurosurg Anesthesiol. 2010 Jul;22(3):187-94. doi: 10.1097/ANA.0b013e3181d48846.
Results Reference
result
Links:
URL
http://doi.org/10.1007/978-1-4614-8951-1
Description
N. Narouze, S. (Ed.). (2014). Interventional Management of Head and Face Pain.
URL
http://doi.org/10.2478/abm-2010-0031
Description
Tuchinda L, Somboonviboon W, Supbornsug K, Worathongchai S, Limutaitip S Asian biomedicine, 2010, 4(2), 243-251
Learn more about this trial
Partial Scalp Block in Posterior Fossa Surgery
We'll reach out to this number within 24 hrs