| CTRI Number |
CTRI/2022/06/043115 [Registered on: 09/06/2022] Trial Registered Prospectively |
| Last Modified On: |
07/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF INFRACLAVICULAR BRACHIAL PLEXUS BLOCK AND COMBINATION OF INFRACLAVICULAR BRACHIAL PLEXUS BLOCK WITH SUPRASCAPULAR NERVE BLOCK FOR SHOULDER SURGERIES IN TERMS OF POST OPERATIVE PAIN MANAGEMENT AND QUALITY OF LIFE. |
|
Scientific Title of Study
|
Comparison of infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries: A Randomised Control Trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Saxena |
| Designation |
Junior Resident |
| Affiliation |
King George medical university |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KING GEORGE MEDICAL UNIVERSITY
LUCKNOW
UTTAR PRADESH
Lucknow UTTAR PRADESH 226003 India |
| Phone |
7754938774 |
| Fax |
|
| Email |
Parul.saxena29@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Manish Kr Singh |
| Designation |
Assistant Professor |
| Affiliation |
KGMU |
| Address |
Department of anaesthesia
King George medical university
Lucknow
Uttar pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9453625852 |
| Fax |
|
| Email |
manish.is.singh34@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Manish Kr Singh |
| Designation |
Assistant Professor |
| Affiliation |
KGMU |
| Address |
Department of anaesthesia
King George medical university
Lucknow
Uttar pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9453625852 |
| Fax |
|
| Email |
manish.is.singh34@gmail.com |
|
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Source of Monetary or Material Support
|
| King George medical university |
|
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Primary Sponsor
|
| Name |
KIng George medical university |
| Address |
King George medical university Lucknow Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Parul saxena |
King George Medical University |
Department of Anaesthesiology and critical care
King George Medical College
Lucknow
Uttar pradesh Lucknow UTTAR PRADESH |
7754938774
Parul.saxena29@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S424||Fracture of lower end of humerus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Brachial plexus block using infraclavicular approach for shoulder surgeries. Sample size is 31 patients in each group over a study duration of three months. |
| Comparator Agent |
Group b |
Brachial plexus block using infraclavicular approach in combination with supra scapular nerve block for shoulder surgeries .
Sample size will be 31 in each group over a duration of three months |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, aged 18-65 years.
Patients giving written informed consent will be taken.
ASA Grade I, II and III
Shoulder Surgeries
|
|
| ExclusionCriteria |
| Details |
morbid obesity
pregnancy
Allergy
Patients not giving consent
Coagulopathy
Local site infections |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries in terms of patient satisfaction.
2. To compare the use of other analgesics in post operative period in infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block with suprascapular nerve block for shoulder surgeries. |
3 months |
|
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Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2022 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Aim: To compare the efficacy of infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia for shoulder surgery . Primary Objectives: To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours. Secondary Objectives: 1. To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries in terms of patient satisfaction. 2. To compare the use of other analgesics in post operative period in infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block with suprascapular nerve block for shoulder surgeries. Study settings: MATERIAL AND METHODS The study will be conducted in Department of Anaesthesiology, King George’s Medical University, Lucknow Study duration: One year Study design: Single blind,Hospital based,Prospective Randomized controlled study Sample Size: 31 in each group. Inclusion Criteria: Patients of either sex, aged 18-65 years. Patients giving written informed consent will be taken. ASA Grade I, II and III Shoulder Surgeries Exclusion criteria morbid obesity pregnancy Allergy Patients not giving consent Coagulopathy Local site infections Methodology: The study will be conducted after getting approval from ethics committee of King Georges Medical University, Lucknow after taking patient’s consent. The patients will be randomly allocated in either of the two groups after fulfilling the inclusion criteria mentioned above using opaque sealed envelope technique. The groups are as follows, STUDY GROUPS • Group-A : brachial plexus block using infraclavicular approach for Shoulder Surgeries • Group-B : brachial plexus block using infraclavicular approach in combination with suprascapular nerve block for Shoulder Surgeries. STUDY PROTOCOL The study will be conducted in a single blind manner where the participants will be blinded to the study. Written and informed consent will be taken from all participants. On the evening before surgery,routine pre-anaesthetic checkup will be done in all patients. Upon arrival to the operating room,routine monitoring including electrocardiography,pulse oximetry and blood pressure monitoring will be done. Part preparation will be done and infraclavicular brachial plexus block and combined infraclavicular Brachial plexus block with suprascapular nerve block will be given according to allocation of the patients in each group under all aseptic conditions. The patients will be monitored for post operative analgesia for a duration of 24 hours at intervals of 1,3,6,12,24 hours using Visual Analogue Scale(VAS SCALE). Patient satisfaction and use of other analgesics in post operative period will also be compared alongside. |