| CTRI Number |
CTRI/2021/01/030405 [Registered on: 12/01/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of superficial cervical plexus block for neck pain due to surgical positioning in patients undergoing burr hole craniotomy for chronic subdural haematoma under regional anaesthesia |
|
Scientific Title of Study
|
Efficacy of superficial cervical plexus block in the management of neck pain due to surgical positioning in patients undergoing burr hole craniotomy for unilateral chronic subdural haematoma under scalp block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KAVITA MEENA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
IMS BHU |
| Address |
DEPT OF ANESTHESIA
S S HOSPITAL
IMS BHU
IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9711897587 |
| Fax |
|
| Email |
kvtamn68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRAGYA SHUKLA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
DEPARTMENT OF ANAESTHIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS BHU
Varanasi
UTTAR PRADESH
221106
India |
| Phone |
9637233147 |
| Fax |
|
| Email |
shukla.prgya0509@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEKHAR ANAND |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
DEPARTMENT OF ANAESTHIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
|
Source of Monetary or Material Support
|
| TRAUMA CENTER INSTITUTE OF MEDICAL SCIENCES BHU |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE ] |
|
|
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 KAVITA MEENA |
TRAUMA CENTER INSTITUTE OF MEDICAL SCIENCES BHU |
DEPARTMENT OF ANAESTHIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH |
9711897587
kvtamn68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: S066||Traumatic subarachnoid hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Superficial cervical plexus block |
Ultrasound guided superficial cervical block with aseptic precaution is given. Linear probe set to higher frequency, probe is placed in a transverse plane on the anterior neck at the level of the midpoint of the line connecting the mastoid process with the insertion of the sternal head of sternocleidomastoid muscle (SCM). The goal is to guide the needle tip from lateral to medial direction just under the tapering posterolateral edge of the SCM to the fascial plane under the SCM and just above the levator scapulae muscle. Aspirate, if no blood comes, inject local anaesthetic solution 1 ml, hydro dissecting the plane between the sternocleidomastoid and levator scapulae muscles and their deep cervical fascias. Further at this point a total 5 ml of the anesthetic mixture(0.5% bupivacaine and 1 ml dexemetomidine50µg/ml) is injected.
|
| Comparator Agent |
SUPERFICIAL CERVICAL PLEXUS BLOCK V/S PLACEBO |
Group SCB: Received scalp block along with superficial cervical block
Group NSCB: Received scalp block without superficial cervical block
IN SCB group- local anaesthetic solution 1 ml, hydro dissecting the plane between the sternocleidomastoid and levator scapulae muscles and their deep cervical fascias. Further at this point a total 5 ml of the anesthetic mixture(0.5% bupivacaine and 1 ml dexemetomidine50µg/ml) is injected.
IN NSCB group- normal saline 1 ml, hydro dissecting the plane between the sternocleidomastoid and levator scapulae muscles and their deep cervical fascias.Further at this point a total 5ml of Normal Saline is injected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Posted for burr hole craniotomy for unilateral chronic subdural haematoma
2. Have negative radiographs of the shoulders and cervical spine
|
|
| ExclusionCriteria |
| Details |
1. h/o of neck shoulder pain radiating to arm radiculopathy
2. Malignancy
3. Hypothyroidism
3. Complete blood count (CBC) with high creatine phosphokinase (CPK)
4. Myopathy
5. Autoimmune diseases that are associated with subclinical myopathy
6. Fibromyalgia
7. coagulopathy
8. Have allergy to bupivacaine
9. 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 |
| Neck pain (assessed by NRS scaling) |
1,2,4,6,24 hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle spasm (assessed by modified Ashworth scale) |
1,2,4,6,24 hours of post operative period |
| consumption of analgesic |
1,2,4,6,24 hours of post operative period |
| patient comfort |
1,2,4,6,24 hours of post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2021 |
| Date of Study Completion (India) |
05/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed to assess the effect of superficial cervical plexus block for managing neck pain in patients of unilateral chronic subdural hematoma to be operated under the scalp block. In a case series of Management of Refractory Neck Pain Secondary to Cervicothoracic Myofascial Pain Syndrome patients received TPI with 0.25% levobupivacaine and reported significant relief for 2 weeks. Thereafter, the patient underwent 3 courses of TPI with a mixture of levobupivacaine and depot steroids and reported relief of 30% lasting 4 weeks after each course. Furthermore, the patient underwent a unilateral iCPB & reported 60% relief at 6-month review. There is myofacial pain due to prolonged surgical positioning of patients during unilateral burr hole awake craniotomy after giving scalp block .So, we hypothesized that ultrasound guided preoperative superficial cervical plexus block will lead to decreased neck pain & relief the muscle spasm that occurs postoperatively in chronic SDH surgery. In the present study neck pain (assessed by NRS scaling) assessed as primary outcome and hemodynamic stability, muscle spasm (assessed by modified Ashworth scale), dose of rescue analgesic required, patients satisfaction score as secondary outcome during post-op period.
|