| CTRI Number |
CTRI/2025/04/084481 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of ultrasound guided nerve plexus block in the neck for pain relief in patient posted for brain surgery with approach from the back of the head : a randomized control trial. |
|
Scientific Title of Study
|
Effect of ultrasound guided superficial cervical plexus block for analgesia
in patients posted for elective neurosurgery via a suboccipital retrosigmoid approach: a
randomized control trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oorjeeta Pal |
| Designation |
Anaesthesia resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
OR office, Department of Anaesthesia, Kasturba Medical College, Manipal, Udupi - 576104
Department of Anaesthesia, Kasturba Medical College, Manipal, Udupi - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09980635250 |
| Fax |
|
| Email |
Oorjeeta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravitej Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Manipal, Karnataka.
Department of Anaesthesia, Kasturba Medical College, Manipal, Udupi - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9449990778 |
| Fax |
|
| Email |
ravitej30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravitej Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Manipal, Karnataka.
Department of Anaesthesia, Kasturba Medical College, Manipal, Udupi - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9449990778 |
| Fax |
|
| Email |
ravitej30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Udupi, Karnataka - 576104, India. |
|
|
Primary Sponsor
|
| Name |
Dr Oorjeeta Pal |
| Address |
Kasturba Medical College, Manipal, Udupi, Karnataka - 576104, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Oorjeeta Pal |
Kasturba Medical College, Manipal |
OR office, Department of Anaesthesia, Manipal, Udupi, Karnataka - 576104,India
Udupi
KARNATAKA |
09980635250
Oorjeeta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
skin infiltration |
skin infiltration with 10 ml of 0.25 % bupivacaine and 100 mcg adrenaline |
| Intervention |
superficial cervical plexus block - ultrasound guided |
10 mL of 0.5%
ropivacaine as analgesic in superficial cervical plexus block - ultrasound guided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
elective suboccipital retro sigmoid craniotomy
America Society of Anaesthesia Status 1 or 2 |
|
| ExclusionCriteria |
| Details |
1. Incision extending beyond the SCPB coverage
2. Surgery extends into the supratentorial fossa
3. Pregnant women
4. History of allergy to ropivacaine/ bupivacaine.
5. Chronic opioids consumption patients
6. Previous history of craniotomy
7. ASA lll and above
8. Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic Parameters in both groups
2. The cumulative consumption of intraoperative opioids |
Post intubation
At the time of block or skin infiltration
At the time of skin infiltration
During surgical incision
Every 1 min during craniotomy
Immediate post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pain severity score
mortality and morbidity |
first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
20/04/2025 |
| 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="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The incidence of intra operative and postoperative pain after neurosurgery is high. The
pain is due to handling of the skin, subcutaneous tissue, craniotomy and dural opening.
Postoperative chronic pain seriously affects patient’s quality of life. Compound local scalp nerve block is a good choice for analgesia for this. However, the
scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach
craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is promising to solve the analgesia requirements
of such surgical approach. At the same time, ultrasound guidance can accurately locate,
ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical
plexus block can safely and effectively reduce the incidence of pain and reduce the
dependence on opioids after a neurosurgery via suboccipital retrosigmoid approach. |