A Phase 1 interventional study of Partial scalp block and Fentanyl in Posterior Fossa Tumor, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Kasr El Aini Hospital · Phase 1, Interventional, and Prevention
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.
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.
Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bilateral block of the greater lesser and third occipital nerves using bupivacaine 0.25% with epinephrine 1:200,000
Drug: Partial scalp block
Fentanyl infusion will be administered till time of dural closure
Drug: Fentanyl
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.).
Also known as: N
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
Also known as: F
Systolic blood pressure at time of skin incision
Recording of the systolic blood pressure in mmhg at the time of skin incision
Time frame: During surgery, 1 min after skin incision
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%
Time frame: During surgery
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 frame: One hour after the surgery
Time for first rescue Analgesia
First time when the patient starts to complain of pain after surgery and an analgesic is given
Time frame: after the surgery
Number of heart beats per minute (Heart rate)
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.
Systolic blood pressure
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.
Mean arterial blood pressure
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.
Diastolic blood pressure
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.
Intraoperative phentolamine consumption
the total amount of phentolamine in mg consumed intraoperatively
Time frame: throughout the operation
Intraoperative ephedrine consumption
the total amount of ephedrine in mg consumed intraoperatively
Time frame: throughout the operation
Time to extubation
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
Plan to share: No
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Infratentorial Neoplasms
Kasr El Aini Hospital