Partial Scalp Block in Posterior Fossa Surgery
Condition: Posterior Fossa Tumor
MeSH terms: Infratentorial Neoplasms
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Partial scalp block; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 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.).; 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
Other intervention name(s): N; F
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Partial scalp block; Posterior fossa surgery; Greater occipital nerve; Lesser occipital nerve; Third occipital nerve; Fentanyl