| CTRI Number |
CTRI/2015/02/005583 [Registered on: 26/02/2015] Trial Registered Prospectively |
| Last Modified On: |
15/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of dexmedetomidine with local anaesthetic for stellate ganglion block in patients scheduled for upper limb surgeries and its effect on requirement of post operative pain relieving drug. |
|
Scientific Title of Study
|
Tramadol sparing effect of dexmedetomidine as an adjuvant in preoperative stellate ganglion block in patients undergoing upper limb surgeries |
| Trial Acronym |
SGB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Thapa |
| Designation |
Associate Professor |
| Affiliation |
Govt Medical College And Hospital Chandigarh |
| Address |
Department of Anaesthesia
Govt Medical College And Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepanshu Dhiman |
| Designation |
post graduate resident |
| Affiliation |
Govt Medical College And Hospital Chandigarh |
| Address |
Department of Anaesthesia
Govt Medical College And Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646308822 |
| Fax |
|
| Email |
panshu88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Thapa |
| Designation |
Associate Professor |
| Affiliation |
Govt Medical College And Hospital Chandigarh |
| Address |
Department of Anaesthesia
Govt Medical College And Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121524 |
| Fax |
|
| Email |
dpkthapa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Govt Medical College And Hospital Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Department of Anaesthesia
Govt Medical College and Hospital
Sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Deepak Thapa |
Department of Anaesthesia |
Govt Medical College And Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH |
9646121524
dpkthapa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, Patients undergoing upper limb surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- patients will receive preoperative stellate ganglion block with 3.5 ml of a solution(3 ml of 2% lignocaine plus 0.5 micrograms/kg dexmedetomidine plus normal saline to make a final volume of 3.5 ml ) and 15 ml of sterile normal saline by intravenous route. |
Patients will receive ultrasound guided preoperative stellate ganglion block with 3.5 ml of a solution(3 ml of 2% lignocaine plus 0.5 micrograms/kg dexmedetomidine plus normal saline to make a final volume of 3.5 ml ) and 15 ml of sterile normal saline by intravenous route. |
| Comparator Agent |
Group 2- patients will receive preoperative stellate ganglion block with 3.5 ml of solution (3 ml 2 % lignocaine plus 0.5 ml of normal saline to make a final volume of 3.5 ml)and 15 ml of sterile normal saline by intravenous route . |
Patients will receive ultrasound guided preoperative stellate ganglion block with 3.5 ml of solution (3 ml 2 % lignocaine plus 0.5 ml of normal saline to make a final volume of 3.5 ml)and 15 ml of sterile normal saline by intravenous route . |
| Comparator Agent |
Group 3- pateints will recieve preoperative stellate ganglion block with 3.5 ml of a solution(3 ml 2% lignocaine plus 0.5 ml of normal saline to make a final volume of 3.5 ml )and 0.5 microgram/ kg of dexmedetomidine diluted in 15 of sterile normal saline by intravenous route. |
Pateints will recieve preoperative stellate ganglion block with 3.5 ml of a solution(3 ml 2% lignocaine plus 0.5 ml of normal saline to make a final volume of 3.5 ml )and 0.5 microgram/ kg of dexmedetomidine diluted in 15 of sterile normal saline by intravenous route. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I &II of either sex
2. Age between 18 to 60 years
3. BMI between 20 to 30 kg m-2
4. Scheduled for upper limb surgery
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal for the procedure.
2. Patients having history of substance abuse.
3. Patients with coagulopathy and bleeding disorders.
4. Pre existing peripheral neuropathy.
5. Pre existing local infection at the site of block.
6. Pregnant and lactating women.
7. Patients having inability to use PCA pump.
8. Contraindication to study drug lignocaine, dexmedetomidine and tramadol.
9. Patients on chronic pain management drugs.
10. Patients with simultaneous acute post operative pain in other parts of the body.
11. Contraindication to general anaesthesia.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study tramadol sparing effect of dexmedetomidine as an adjuvant with lignocaine in preoperative stellate ganglion block for postoperative pain relief following upper limb surgeries. |
In post anaesthesia care unit 0 hours
2 hours
4 hours
6 hours
8 hours
12 hours
24 hours
36 hours
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Preoperative -haemodynamics,VAS at rest and on movement,temperature in operative limb, eye signs(chemosis,ptosis,miosis) and ramsay sedation score;Intraoperatively-haemodynamics,oxygen saturation,end tidal Et CO2;
Post operatively-haemodynamics,VAS at rest and on movement,adverse effects,ramsay sedation score and patient satisfaction score. |
preoperatively-baseline,5 min after block and every 5 mins till 15 min after block placement;Intraoperatively every 5 mins till end of surgery;postoperatively 0 hours,2 hours,4 hours,6 hours,8 hours,12 hours,24 hours,36 hours and 48 hours. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in the BRITish Journal of pain |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In recent years greater emphasis is being laid on the management of post operative pain relief..Peripheral nerve blocks for upper limb surgeries have shown to provide better outcome in terms of pain relief and patient statisfaction .Peripheral nerve blocks are also associated with enhanced participation of patients in rehabilitation phase thus reducing hospital cost and stay.Role of autonomic nervous system in control of chronic pain has been described in literature in patients of complex regional pain syndrome. Mc Donell et al have demonstrated the role of autonomic nervous system in management of acute post operative pain .In his case series preoperative stellate ganglion block was given to patients undergoing operative treatment for humerus fractures and effective postoperative analgesia was reported upto 48 hours.Further a recent randomised control trial conducted by Kumar et al demonstrated a postoperative tramadol sparing effect following preoperative stellate ganglion in patients undergoing upper limb orthopaedic surgery under general anaesthesia.The role of stellate ganglion block in postoperative pain relief has now been establised for upper limb surgeries.Literature describes the role of various adjuvants to peripheral nerve blocks .As most patients report increased pain during night hours when access to care is limited adjuvants have been used to increase duration of pain relief as well as requirement of analgesic medication postoperatively.Dexmedetomidine is an alpha 2 agonist having both sedative and analgesic properties. Use of dexmedetomidine in various nerve blocks as an adjuvant and also in cervical plexsus block has shown to shorten the sensory block onset time and extended the duration of analgesia.A through search of literature did not reveal any study using dexmedetomidine as an adjuvant with local anaesthetic in stellate ganglion block .We hypothesise that the addition of dexmedetomidine to lignocaine during preoperative ultrasound guided stellate ganglion block will have no effect on postoperative cumulative tramadol consumption at 48 hours in patients scheduled for upper limb surgeries under general anaesthesia.
Sample size calculation-As per a pilot study conducted for tramadol sparing effect of preoperative stellate ganglion block for postoperative pain relief in patients undergoing upper limb surgeries the mean tramadol consumption came out to be 130 mg with standard deviation of 14.1.To estimate a difference of consumption of 10 % tramadol our sample size came out to be 15 patients per group ,with a power of 80% and confidence interval of 95%.Considering a drop out rate of 20 % the sample size came out to be 18 patients in each group.
Primary outcome-To study tramadol sparing effect of dexmedetomidine as an adjuvant with lignocaine in preoperative stellate ganglion block for postoperative pain relief following upper limb surgeries. Secondary outcome-To study perioperative pain relief ,haemodynamics and adverse effects of preoperative stellate ganglion block in patients scheduled for upper limb surgeries.
Result : The cumulative tramadol consumption at the end of 48 hours (p=0.01) was significantly reduced in the group I as compared to group II . In group I postoperative vas at rest was significantly reduced up to n12 hours potoperatively as compared to group II (p= 0.05). the cumulative tramadol consumpotion was not reduced significantly in group III compared to group II (p=0.51).
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