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Partial Scalp Block in Posterior Fossa Surgery

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ClinicalTrials.gov Identifier: NCT04955236
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Rania Samir Fahmy, Kasr El Aini Hospital

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.

Condition or disease Intervention/treatment Phase
Posterior Fossa Tumor Drug: Partial scalp block Drug: Fentanyl Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Partial Scalp Block Versus Fentanyl Infusion in Patients Undergoing Posterior Fossa Surgery Under General Anesthesia. A Randomized Control Trial
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Partial scalp block
Bilateral block of the greater lesser and third occipital nerves using bupivacaine 0.25% with epinephrine 1:200,000
Drug: Partial scalp block

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.).

Other Name: N

Active Comparator: Fentanyl group
Fentanyl infusion will be administered till time of dural closure
Drug: Fentanyl
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 Name: F




Primary Outcome Measures :
  1. Systolic blood pressure at time of skin incision [ Time Frame: During surgery, 1 min after skin incision ]
    Recording of the systolic blood pressure in mmhg at the time of skin incision


Secondary Outcome Measures :
  1. Intraoperative fentanyl boluses [ Time Frame: During surgery ]
    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%

  2. RASS score [ Time Frame: One hour after the surgery ]
    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

  3. Time for first rescue Analgesia [ Time Frame: after the surgery ]
    First time when the patient starts to complain of pain after surgery and an analgesic is given

  4. Heart rate [ 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. ]
    Number of heart beats per minute

  5. Systolic blood pressure [ 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. ]
    systolic blood pressure in mmhg

  6. Mean arterial blood pressure [ 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. ]
    Mean arterial blood pressure in mmhg

  7. Diastolic blood pressure [ 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 in mmhg

  8. Intraoperative phentolamine consumption [ Time Frame: throughout the operation ]
    the total amount of phentolamine in mg consumed intraoperatively

  9. Intraoperative ephedrine consumption [ Time Frame: throughout the operation ]
    the total amount of ephedrine in mg consumed intraoperatively

  10. Time to extubation [ Time Frame: At the end of the operation, the time from the discontinuation of inhalation agents till extubation ]
    It is the time between closure of inhalational anesthetic and extubation



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04955236


Contacts
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Contact: Rania S Fahmy 01270820372 ransam98@gmail.com

Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Rania S Fahmy Kasr Al Ainy, Faculty of medicine, Cairo university
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Rania Samir Fahmy, Assistant professor of Anesthesia, ICU and pain medicine, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04955236    
Other Study ID Numbers: MS-317-2020
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rania Samir Fahmy, Kasr El Aini Hospital:
Partial scalp block
Posterior fossa surgery
Greater occipital nerve
Lesser occipital nerve
Third occipital nerve
Fentanyl
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Central Nervous System Diseases
Central Nervous System Depressants
Brain Diseases
Nervous System Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics