CTRI/2025/05/086358 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On:
04/05/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Medical Device Surgical/Anesthesia Screening Other (Specify)
Study Design
Single Arm Study
Public Title of Study
cranial vs cervical approach of ultrasound guided greater occipital nerve block in patients undergoing posterior fossa craniotomy
Scientific Title of Study
Comparison of efficacy of cranial vs cervical approach of ultrasound guided greater occipital nerve block in patients undergoing posterior fossa craniotomy: A randomized controlled study
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
Nil
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Sandhya
Designation
Junior Resident
Affiliation
King Georges Medical University Lucknow
Address
Department of Anaesthesiology,
Gandhi memorial and Associated Hospital,
King George Medical University, Chowk, Shahmina Road Lucknow
Lucknow
Lucknow UTTAR PRADESH 226003 India
Phone
7275936495
Fax
Email
sandhyanath247@gmail.com
Details of Contact Person Scientific Query
Name
Prof Ajay Kumar Chaudhary
Designation
Professor
Affiliation
King Georges Medical University Lucknow
Address
Department of Anaesthesiology,
Gandhi memorial and Associated Hospital,
King George Medical University,
Chowk Shahmina Road Lucknow Lucknow UTTAR PRADESH 226003 India
Phone
9415022374
Fax
Email
ajaychaudhary62@yahoo.com
Details of Contact Person Public Query
Name
Prof Ajay Kumar Chaudhary
Designation
Professor
Affiliation
King Georges Medical University Lucknow
Address
Department of Anaesthesiology,
Gandhi memorial and Associated Hospital,
King George Medical University,
Chowk Shahmina Road Lucknow Lucknow UTTAR PRADESH 226003 India
Phone
9415022374
Fax
Email
ajaychaudhary62@yahoo.com
Source of Monetary or Material Support
Operation theater Room No. 1
Department of Anaesthesiology,
Gandhi memorial and Associated Hospital,
King George Medical University, Chowk, Shahmina Road Lucknow 226003 Uttar Pradesh
Primary Sponsor
Name
Operation Theater
Address
Operation theater Room No. 1 Department of Anaesthesiology, Gandhi memorial and Associated Hospital, King George Medical University, Chowk, Shahmina Road Lucknow 226003 Uttar Pradesh
Type of Sponsor
Government medical college
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Prof Ajay Kumar Chaudhary
Operation Theater
Department of Anaesthesiology,
Gandhi memorial and Associated Hospital,
King George Medical University, Chowk, Shahmina Road Lucknow
Lucknow UTTAR PRADESH
9415022374
ajaychaudhary62@yahoo.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: S048||Injury of other cranial nerves,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
The comparator in this study involves the cranial and cervical approaches for ultrasound-guided greater occipital nerve block (GONB). Patients receiving the cranial approach serve as the intervention group, while those receiving the cervical approach constitute the comparator group. Outcomes such as postoperative pain scores, analgesic requirement, duration of analgesia, and patient satisfaction will be assessed between these two techniques.
The comparator in this study involves the cranial and cervical approaches for ultrasound-guided greater occipital nerve block (GONB). Patients receiving the cranial approach serve as the intervention group, while those receiving the cervical approach constitute the comparator group. Outcomes such as postoperative pain scores, analgesic requirement, duration of analgesia, and patient satisfaction will be assessed between these two techniques.
Intervention
This study compares the efficacy of cranial and cervical ultrasound-guided greater occipital nerve block (GONB) techniques in patients undergoing posterior fossa craniotomy. Intervention includes administering GONB using either the cranial or cervical approach preoperatively. The primary outcome is pain intensity reduction, while secondary outcomes include analgesic consumption, patient satisfaction, and duration of analgesia.
Study population parameters will be include all adult patients (age 18-65), undergoing elective posterior fossa craniotomy, with American Society of Anesthesiologists (ASA) physical status I-III
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Study population parameters will be include all adult patients (age 18-65), undergoing elective posterior fossa craniotomy, with American Society of Anesthesiologists (ASA) physical status I-III
ExclusionCriteria
Details
Exclusion criteria should include patients with a history of chronic pain, prior nerve blocks, allergy to study medications, or contraindications to ultrasound-guided procedures. Randomization should be stratified by age and sex.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
The primary outcome was the OPS score at 12 hours postoperatively
The primary outcome was the OPS score at 12 hours postoperatively
Secondary Outcome
Outcome
TimePoints
Secondary outcomes were: (1) OPS scores at 2, 4, 6, 8, 16, and 24 hours postoperatively; (2) duration of analgesia, defined as the time to the first postoperative analgesic request; (3) cumulative intraoperative fentanyl dose; (4) intraoperative heart rate and systolic blood pressure at baseline, skin incision, dural incision, 1-hour postintubation, 2-hour postintubation, 3-hour postintubation, dural closure, and skin closure; (5) postoperative heart rate and systolic blood pressure at 2, 4, 6, 8, 12, 16, and 24-hour post procedure; (6) incidence of postoperative nausea and vomiting, and; (7) incidence of nerve-block complications, namely scalp hematoma or inadvertent subarachnoid or intravascular injection of local anesthetic
Secondary outcomes were: (1) OPS scores at 2, 4, 6, 8, 16, and 24 hours postoperatively; (2) duration of analgesia, defined as the time to the first postoperative analgesic request; (3) cumulative intraoperative fentanyl dose; (4) intraoperative heart rate and systolic blood pressure at baseline, skin incision, dural incision, 1-hour postintubation, 2-hour postintubation, 3-hour postintubation, dural closure, and skin closure; (5) postoperative heart rate and systolic blood pressure at 2, 4, 6, 8, 12, 16, and 24-hour post procedure; (6) incidence of postoperative nausea and vomiting, and; (7) incidence of nerve-block complications, namely scalp hematoma or inadvertent subarachnoid or intravascular injection of local anesthetic
Target Sample Size
Total Sample Size="50" Sample Size from India="50" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
30/05/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
COMPARISON OF EFFICACY OF
CRANIAL VS CERVICAL APPROACH OF ULTRASOUND GUIDED GREATER OCCIPITAL NERVE BLOCK
IN PATIENTS UNDERGOING POSTERIOR FOSSA CRANIOTOMY: A RANDOMISED, CONTROLLED
STUDY
INTRODUCTION
Posterior fossa craniotomy is a neurosurgical
procedure that is often associated with postoperative headaches, which can
significantly impact the quality of life and recovery of patients. Despite
advancements in anesthesia and pain management, effective strategies for
mitigating postoperative pain in this specific patient population remain a
challenge. Greater occipital nerve (GON) block has been used successfully in
pediatric patients to treat chronic primary headache disorders and manage
postoperative pain after ventricular shunt revision. Ultrasound guidance
enhances the precision and safety of nerve block procedures, offering the
potential for improved outcomes.
However, the choice between cranial and cervical approaches for greater
occipital nerve block in the context of posterior fossa craniotomy remains a
topic of debate and limited research. Previous research emphasizes the
significance of providing neurosurgical patients with appropriate pain
management, with a focus on the possible benefits of regional anaesthesia
techniques for improving recovery. However, the finer points of contrasting the
cervical and cranial methods for greater occipital nerve block in this context
are not fully discussed.
Several studies have investigated the efficacy of greater occipital nerve block
in different clinical scenarios, demonstrating varying degrees of success.
However, a paucity of research directly comparing the cranial and cervical
approaches in the unique context of posterior fossa craniotomy prompts the need
for a focused and rigorous investigation. Understanding the anatomy and
innervation of the greater occipital nerve in relation to the surgical site is
crucial for interpreting the potential efficacy of different approaches.
Pingree MJ et al (2017) conducted a prospective open-label study that
demonstrated successful blockade of the GON at the level of C2 using a novel
ultrasound-guided technique. The observations from this study provide important
preliminary data for future randomized trials involving patients with occipital
neuralgia and cervicogenic headache.
Flamer et al (2019) conducted a multicenter, prospective, randomized control
trial that compared the accuracy, effectiveness, and safety of these two
techniques in patients with chronic migraines (CMs). The primary outcome was
the difference in Numerical Rating Score (NRS) for headache intensity at 1
month. Secondary outcomes included effectiveness, performance, and
safety-related outcomes. NRS pain scores were significantly reduced at 24 hours
and at 1 week post procedure in both cohorts and at 1 and 3 months in the
proximal group as compared with the baseline. There was no significant
difference in NRS pain scores between the two cohorts at any of the follow-up
time points.
This study compared two different US-guided approaches for blocking the GON,
demonstrating that both distal and proximal techniques can provide short-term
improvements in headache intensity, reduced number of headache days per week,
and improved sleep interruption. The proximal GON technique may confer more
sustained analgesic benefit compared with the distal approach in patients with
chronic migraine headaches.
USG to block the nerves of the scalp is easy and may improve patient safety by
reducing the total amounts of LA used and lowering the risk of vascular
puncture. Additionally, USG might allow for a more precise nerve location due
to numerous variations in nerve foramina or course.
Chowdhary et al (2020) studied 532 articles, 9 open-label and 4
placebo-controlled trials that studied the role of GON block for prevention of
CM. Open-label trials reported a reduction of headache severity and frequency
in 35–68% of patients, with the beneficial effect of a single block lasting up
to 4 weeks. Randomized controlled trials (RCTs) used varied methodology and
techniques of GON block, and the outcomes were reported at different time
points. A single RCT showed a beneficial effect of the GON block at 1 week, but
the GON block was found to be safe and well tolerated.
Muse et al (2021) discussed regional anesthetic techniques that can be used for
primary anesthesia and analgesia, or in combination with general anesthesia.
Nassar H et al (2023) conducted a prospective randomized controlled study that
found that the GON block group was associated with superior quality and
duration of postoperative analgesia and better hemodynamic profile compared to
standard care.
Stern JI, et al (2022) studied 12 RCTs examining the use of greater occipital
nerve blocks for migraine, all but one showing efficacy with reduction in
headache frequency, intensity, and/or duration compared to placebo. Studies
have not demonstrated a difference in clinical outcomes with the use of
corticosteroids for nerve blocks compared to blocks with local anesthetic in
the treatment of migraine.
Observational studies and case series/reports show that greater occipital nerve
block may be effective in prolonged migraine aura, status migraineurs,
post-dural puncture headache, and occipital neuralgia. Overall, peripheral
nerve blocks are well tolerated, and serious side effects are rare but have
been reported, including acute cerebellar syndrome and infection. Peripheral
nerve blocks, especially occipital nerve blocks, are a viable treatment option
for migraine and may be helpful in cluster headache as a transitional therapy
or rescue therapy.
AIMS AND OBJECTIVES
Aim:
·To compare the efficacy of ultrasound-guided greater
occipital nerve block using cranial and cervical approaches in patients
undergoing posterior fossa craniotomy.
Objectives:
Primary:
·To compare the postoperative pain using Numeric Rating Scale
(NRS)
Secondary:
·To compare the hemodynamics in perioperative period
·To compare the sedation score using Ramsay Sedation Score
(RSS)in post operative period
·To compare the time to first analgesic request, and total analgesic
consumption
·To compare the neurological outcome using Extended Glasgow Outcome
Scale (GOSE)
·To observe the complications
MATERIAL AND METHODS
Study Settings: The study will be conducted in Department of
Anesthesiology, King George’s Medical University, Lucknow.
Study design:Prospective
Randomized Controlled Study
Study duration: 1 year
Sample size: 25 in each group
Inclusion Criteria:
·Patients of either sex, and aged between 18 to 60
years
·Elective posterior fossa craniotomy
·American Society of Anesthesiologists (ASA)
physical status I to II
Exclusion Criteria:
·Patient’s Refusal
·Allergy to local anesthetics
·Pre-existing neurological or psychiatric
conditions
·History of chronic headache disorders (e.g.,
migraine, tension-type headache).
·Pregnancy or Lactation
·Coagulopathy
·Previous Craniotomy
·Participation in other clinical trials
concurrently
STUDY PROTOCOL
Ethical
clearance and Written and Informed consent will be taken.The study will be done
at King George Medical University,
Lucknow.Randomization will be performed using computer-generated random
numbers to ensure a balanced distribution of potential confounding factors. All
participants will be randomly assigned to one of two groups:
·Cranial Approach Group
·Cervical Approach Group
The study aims to record
demographic data, signs and symptoms, number of surgical accesses, and
fixations of patients scheduled for posterior fossa craniotomy. Postoperative
headaches are at risk for all patients, and informed consent is required to
understand the potential benefits and risks of both cranial and cervical
approaches. Procedure details, ultrasound-guided techniques, needle size, and
injection volume are specified. Standardized anesthesia protocols are used for
both groups to ensure consistency in perioperative care. Postoperative pain is
assessed using the objective pain scale (OPS), based on five criteria: systolic
arterial blood pressure, crying, movement, agitation, and verbal evaluation.
The worst OPS score is 10 if the child is old enough to complain of pain, and 8
if too young. In the ICU, intravenous paracetamol is given and repeated every 6
hours for patients who first complained of pain, while ketorolac is
administered every 8 hours for persistent or breakthrough pain. Outcomes include
the OPS score at 12 hours postoperatively, duration of analgesia, cumulative
intraoperative fentanyl dose, intraoperative heart rate and systolic blood
pressure, incidence of postoperative nausea and vomiting, and incidence of
nerve-block complications, such as scalp hematoma or inadvertent subarachnoid
or intravascular injection of local anesthetic.
Statistical analysis
Statistical analysis was performed by the SPSS version 23rd
version. Continuous variables were presented as mean±SD and categorical
variables were presented as absolute numbers and percentage. Normally
distributed continuous variables and categorical variables were compared using
appropriate statistical test. P value less than 0.05 was taken as significant.