Partial Scalp Block in Posterior Fossa Surgery

NCT04955236 | Completed Phase 1

• 1 other identifier: MS-317-2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Fossa Tumor

Keywords

Partial scalp block; Posterior fossa surgery; Greater occipital nerve; Lesser occipital nerve; Third occipital nerve; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure at time of skin incision

  Recording of the systolic blood pressure in mmhg at the time of skin incision

  During surgery, 1 min after skin incision

Secondary Outcomes (10)

• Number of intraoperative fentanyl boluses

  During surgery

• RASS score

  One hour after the surgery

• Time for first rescue Analgesia

  after the surgery

• Number of heart beats per minute (Heart rate)

  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

  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.

Study Arms (2)

Partial scalp block

EXPERIMENTAL

Bilateral block of the greater lesser and third occipital nerves using bupivacaine 0.25% with epinephrine 1:200,000

Drug: Partial scalp block

Fentanyl group

ACTIVE COMPARATOR

Fentanyl infusion will be administered till time of dural closure

Drug: Fentanyl

Interventions

Partial scalp block DRUG

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

Partial scalp block

Fentanyl DRUG

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

Fentanyl group

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, 11687, Egypt

Location

Related Publications (4)

• 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.

  PMID: 26929661 BACKGROUND

• 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.

  PMID: 8942596 BACKGROUND

• 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.

  PMID: 24966149 BACKGROUND

• 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.

  PMID: 20479675 RESULT

Related Links

• N. Narouze, S. (Ed.). (2014). Interventional Management of Head and Face Pain.
• Tuchinda L, Somboonviboon W, Supbornsug K, Worathongchai S, Limutaitip S Asian biomedicine, 2010, 4(2), 243-251

MeSH Terms

Conditions

Infratentorial Neoplasms

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rania S Fahmy

  Kasr Al Ainy, Faculty of medicine, Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia, ICU and pain medicine

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 8, 2021
• Study Start: July 14, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)