| CTRI Number |
CTRI/2022/02/039972 [Registered on: 02/02/2022] Trial Registered Prospectively |
| Last Modified On: |
01/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of blocking the nerves supplying scalp and local site infiltration in preventing increase in blood pressure during awake deep brain stimultion surgeries |
|
Scientific Title of Study
|
Comparison of scalp block vs local anaesthetic infiltration in preventing intraoperative hypertension in patients undergoing awake deep brain stimulation surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR FAHMEENA BEGUM |
| Designation |
SENIOR RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA, HYDERABAD, TELANGANA
Hyderabad
TELANGANA
500082
India |
| Phone |
9573633765 |
| Fax |
|
| Email |
fahmeena27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR FAHMEENA BEGUM |
| Designation |
SENIOR RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA, HYDERABAD, TELANGANA
Hyderabad
TELANGANA
500082
India |
| Phone |
9573633765 |
| Fax |
|
| Email |
fahmeena27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR FAHMEENA BEGUM |
| Designation |
SENIOR RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA, HYDERABAD, TELANGANA
Hyderabad
TELANGANA
500082
India |
| Phone |
9573633765 |
| Fax |
|
| Email |
fahmeena27@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.FAHMEENA BEGUM, NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA, HYDERABAD |
|
|
Primary Sponsor
|
| Name |
DR FAHMEENA BEGUM |
| Address |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| 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 FAHMEENA BEGUM |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, NIZAMS INSTITUTE OF MEDICAL SCIENCES |
NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA
Hyderabad
TELANGANA |
9573633765
fahmeena27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, (2) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local infiltration |
30 ml of local anaesthetic (0.5% Bupivacaine 15 ml + 2% xylocard 7 ml + 8 ml saline). 15 ml on each side i.e right and left Local infiltration by the surgeon at the beginning of surgery. |
| Intervention |
Scalp Block |
30 ml of local anaesthetic (0.5% Bupivacaine 15 ml + 2% xylocard 7 ml + 8 ml saline). 15 ml on each side i.e right and left side given as scalp block by the anaesthetist via landmark technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1. ASA I,II,III
2. Age 18-70 yrs
3. Patients posted for Deep brain stimulation procedures.
4. Duration of DBS procedure lasting for 3-4 hours |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Patients not willing to participate
2. Bleeding disorders or coagulopathies
3. Cardiac or respiratory compromise
4. Allergic to local anaesthetics
5. Local site infection.
POST INCLUSION EXCLUSION CRITERIA:
1. Any intraoperative need for conversion to general controlled anaesthesia.
2. Any intraoperative complications observed (airway or respiratory compromise, seizures, cardiovascular compromise – needing either intubation or abandoning of procedure). |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of episodes of intraoperative hypertension in patients with local infiltration and with scalp block. |
1. Vitals every 15 minutes for upto 4 hours from the beginning of surgery especially at: Infiltration, Incision, Burr hole, Dural coagulation, Dural cutting, Closure.
2. Number of hypertensive episodes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antihypertensive requirement |
During surgery |
| Analgesic requirements |
During surgery |
| Sedative requirement |
During the Surgery |
| Surgeon and neurologist satisfaction score |
During the surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/02/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Placement of Deep brain stimulation electrodes is a stereotactically guided procedure for treatment of movement disorders (Parkinson disease, essential tremor, dystonias). Acute rise in blood pressure can precipitate intracranial hemorrhage especially during multiple passage of needles. Regional anaesthesia of scalp is essential for providing adequate intraoperative analgesia thus reducing intraoperative acute hypertension. Also, it reduces the doses of intraoperative analgesics and anti-hypertensives. It allows the surgeon for accurate placement of electrodes, improving the success rate of the surgery, which would have been difficult if done with sedation and general anaesthesia as verbal communication with the patient during the procedure is quite essential. Different modalities of regional anaesthesia of scalp commonly used are scalp block and local infiltration anaesthesia.
This study is designed to compare the effects of local infiltration and scalp block in preventing intaoperative hypertension in deep brain stimulation surgeries. There has been a single study till date comparing these two modalities of anaesthesia in such surgeries.
OBJECTIVES:
PRIMARY OBJECTIVE: To compare the number of episodes of intraoperative hypertension in patients with local infiltration and with scalp block.
SECONDARY OBJECTIVES: To compare requirement of analgesics, anti-hypertensives, sedatives, surgeon’s and neurologist’s satisfaction and perioperative complications in both groups.
PLACE OF STUDY:
This study will be conducted in the Department of Anaesthesia and Intensive Care, Nizam’s Institute of Medical Sciences from September 2021 to September 2022 (Single Institute).
STUDY DESIGN:
A Randomized comparative analysis will be conducted in 60 patients who are posted for Deep brain stimulation surgery, satisfying the inclusion and exclusion criteria. They will be divided
randomly into two equal groups based on the modality of regional anaesthesia to be used and will be labelled as: Group L and Group S. Pre-operatively, Group L patients will receive 30 ml of local anaesthetic (15 ml of 0.5% Bupivacaine + 7 ml of 2% Lignocaine + 8 ml saline) in the sites of burr holes (i.e 2 sites-right and left, 15 ml in each site), by the surgeon. Group S patients will receive Scalp block with a total of 30 ml local anaesthetic (15 ml of 0.5% Bupivacaine + 7 ml of 2% Lignocaine + 8 ml saline) 15 ml on each side- right and left, by the anaesthesiologist.
PARAMETERS TO BE RECORDED: All these parameters will be recorded intraoperatively for upto 4 hours after the beginning of surgery.
1. Vitals every 15 minutes for upto 4 hours from the beginning of surgery especially at: Infiltration, Incision, Burr hole, Dural coagulation, Dural cutting, Closure.
2. Number of hypertensive episodes.
3. Anti-hypertensive medications and their doses
4. Analgesics and their doses
5. Sedatives and their doses
6. Surgeon’s and neurologist’s satisfaction for electrode placement.
INCLUSION CRITERIA:
1. ASA I,II,III
2. Age 18-70 yrs
3. Patients posted for Deep brain stimulation procedures.
4. Duration of DBS procedure lasting for 3-4 hours
EXCLUSION CRITERIA:
1. Patients not willing to participate
2. Bleeding disorders or coagulopathies
3. Cardiac or respiratory compromise
4. Allergic to local anaesthetics
5. Local site infection.
POST INCLUSION EXCLUSION CRITERIA:
1. Any intraoperative need for conversion to general controlled anaesthesia.
2. Any intraoperative complications observed (airway or respiratory compromise, seizures, cardiovascular compromise – needing either intubation or abandoning of procedure).
STUDY HYPOTHESIS:
Scalp block is superior over local anaesthetic infiltration in preventing intraoperative hypertension in patients undergoing awake deep brain stimulation surgery.
Results will be published after the study. |