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CTRI Number  CTRI/2017/02/007851 [Registered on: 14/02/2017] Trial Registered Prospectively
Last Modified On: 15/01/2019
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   The study will find the difference in pain killer drug consumption (tramadol) when neck (stellate ganglion) block is given before surgery with or without study drug (dexamethasone) in patients undergoing arm surgeries.  
Scientific Title of Study   Tramadol sparing effect of dexamethasone as an adjuvant in preoperative stellate ganglion block in patients undergoing upper limb surgeries. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
None  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Deepak Thapa 
Designation  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  09646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjot Singh 
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  09501566078  
Fax    
Email  manjotdoc91@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Deepak Thapa 
Designation  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  09646121524  
Fax    
Email  dpkthapa@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Govt. Medical College and Hospital Sector 32, Chandigarh 
 
Primary Sponsor  
Name  Department of Anaesthesia 
Address  Government Medical College and Hospital Sector 32 Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Deepak Thapa  Department of Anaesthesia, GMCH 32, Chandigarh  Govt. Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH 
09646121524

dpkthapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 3 Stellate ganglion block with lignocaine plus intravenous Dexamethasone   Preoperative ultrasound guided with Stellate ganglion block 4 ml of a solution (3 ml 2% lignocaine + 1 ml normal saline to make final volume of 4 ml) and intravenous 15 ml of normal saline with dexamethasone (4 mg) 
Intervention  Group 1 Stellate ganglion block with lignocaine and adjuvant Dexamethasone plus intravenous normal saline   Preoperative ultrasound guided with Stellate ganglion block 4 ml of a solution (3 ml 2% lignocaine + 1 ml dexamethasone (4mg) to make final volume of 4 ml) and 15 ml of normal saline by IV route 
Comparator Agent  Group 2 Stellate ganglion block with lignocaine plus intravenous normal saline  Preoperative ultrasound guided with Stellate ganglion block 4 ml of a solution (3 ml 2% lignocaine + 1 ml normal saline to make final volume of 4 ml) and 15 ml of normal saline by IV route 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1. ASA physical status I & II of either sex
2. Age between 18 to 60 years
3. BMI ≥ 20 to ≤ 30 kg m-2
4. Scheduled for major 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, dexamethasone 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.
 
 
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 dexamethasone as an adjuvant in preoperative stellate ganglion block in patients undergoing 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 
1. Visual analogue scale at rest and on movement in patients receiving Stellate ganglion block scheduled for upper limb surgeries.
2. Haemodynamics in patients receiving Stellate ganglion block scheduled for upper limb surgeries.
3. Adverse effects of preoperative Stellate ganglion block in patients scheduled for upper limb surgeries.
4. Patient’s satisfaction score
5. Temperature in the operative limb (ËšC), Chemosis, Ptosis, Miosis.  
1 to 3. Preoperatively - baseline, 5 min after block and every 5 mins till 15 min after block placement, post operative 0 ,2,4,6,8,12,24,36 and 48 hours

4. 24 and 48 hours
5. Preoperatively - baseline, 5,10,15 mins 
 
Target Sample Size   Total Sample Size="57"
Sample Size from India="57" 
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/03/2017 
Date of Study Completion (India) 13/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 13/05/2018 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Acute postoperative pain begins with surgical trauma and ends with tissue healing. Post operative pain if not adequately managed leads to untoward events such as pain, reduced organ function and prolonged hospital stay. A greater emphasis is now being laid on the management of post operative pain relief. Following surgical procedures, the nociceptive signals increase the autonomic reflexes, metabolic and endocrine responses, thereby causing a delay in the restoration of body functions. Hence, appropriate management of post operative pain is necessary. The most commonly used pharmacological agents are opioids and non-steroidal anti-inflammatory drugs (NSAIDs). There are a number of side effects associated with the use of opioids namely nausea, vomiting, respiratory depression and sedation. NSAIDs, on the other hand, are associated with decreased hemostasis, gastrointestinal bleeding and renal dysfunction. Due to these adverse events, regional anaesthetic techniques are being increasingly used. It helps to reduce the consumption of such analgesic medications and their associated adverse events.

In upper limb surgery pain relief is the major concern for the anesthesiologist. In published literature, high opioid consumption has been observed in surgeries for fracture of humerus during intra and post operative period.3 Intravenous (IV) opioid through patient controlled analgesia is associated with side effects but its use with peripheral nerve blocks have shown to provide better outcome in terms of pain relief and patient satisfaction.  Recently, use of ultrasound guidance for peripheral nerve blocks has reduced the complication rate leading to decreased hospital stay and reduced cost.

The role of sympathetic nervous system has been established in chronic pain states like complex regional pain syndrome (CRPS). Mc Donell et al demonstrated the role sympathetic nervous system in a case series of four patients undergoing operative treatment for humeral fractures. Stellate ganglion block (SGB) with local anaesthetic was given to patients preoperatively and effective post operative analgesia up to 48 hours was reported. In patients undergoing upperlimb surgeries, Kumar et al conducted the first randomised controlled trial to evaluate the role of pre operative SGB on post operative analgesia. In the lignocaine group the mean hourly tramadol consumption was significantly reduced as compared to the saline group. The study of Kumar et al demonstrated a postoperative tramadol sparing effect following pre operative SGB in patients undergoing upper limb orthopaedic surgery under general anaesthesia.

Stellate ganglion block has an established role in upper limb surgeries now. At times when the access to medical care is limited maximum reporting of pain was made. The role of adjuvants to peripheral nerve blocks which increase the duration of analgesia and reduce requirement of analgesics has also been described in the literature. 

Corticosteroids are widely used in peripheral nerve blocks for acute pain control and injected in the epidural space to treat radicular pain.7 Dexamethasone, a high potency, long acting corticosteroid commonly used to treat post operative nausea, vomiting and pain, and is considered a good candidate to augment block duration. Dexamethasone prolongs peripheral nerve block when added to short acting local anaesthetics. Intravenous dexamethasone has been shown to attenuate the post operative need for analgesics in different clinical settings, including after orofacial, general, urological and orthopedic surgeries.

So far, no study had compared tramadol sparing effect of addition of dexamethasone to lignocaine during preoperative SGB or IV with control in upper limb surgeries. Therefore the present study was planned to evaluate the tramadol sparing effect of addition of dexamethasone to lignocaine during preoperative SGB in upper limb surgeries. 

As per pilot cases conducted for tramadol sparing effect of preoperative SGB for postoperative pain relief in patients undergoing upper limb surgeries the mean tramadol consumption was 130 mg with standard deviation of 24.To estimate a difference of consumption of 20% tramadol our sample size came out to be 16 patients per group, with a power of 80% and confidence interval of 95%.Considering a dropout rate of 20% the sample size came out to be in 19 patients per group.

The present study was a prospective, randomised, double blind, placebo controlled clinical trial which was started after approval from the institute ethics committee (EC/2016/0070) dated 5.12.2016 and registration with Clinical trial registry of India (CTRI/2017/02/007851). The study evaluated the tramadol sparing effect of dexamethasone as an adjuvant to lignocaine in pre operative SGB in patients undergoing upper limb surgeries.

Fifty seven patients (19 per group) of ASA grade I-II, aged 18-60 years of either sex having BMI 18-30 kg.m-2 scheduled to undergo upper limb orthopaedic surgery under general anaesthesia were enrolled in the study after taking written informed consent.

A preoperative SGB was given in all the patients. Using a para-tracheal out of plane technique (between thyroid gland and common carotid artery), a blunt regional anaesthesia needle (22G, 50mm Stimuplex A; BBraun, Melsung, Germany) was advanced after retracting the carotid artery laterally and directing towards the longus colli muscle. Following which 4 ml of study drug per group allocation was given sub fascially.

SGBDex (n = 19) received preoperative ultrasound guided SGB with 4 ml of a solution (3 ml 2% lignocaine + 1 ml dexamethasone (4mg) = final volume of 4 ml) and 15 ml of normal saline by IV route.

SGBC (n = 19) received preoperative ultrasound guided SGB with 4 ml of a solution (3 ml 2% lignocaine + 1 ml normal saline = final volume of 4 ml) and 15 ml of normal saline by IV route.

SGBIV (n = 19) received preoperative ultrasound guided SGB with 4 ml of a solution (3 ml 2% lignocaine + 1 ml normal saline = final volume of 4 ml) and 1 ml dexamethasone (4mg) diluted in 15 ml of normal saline by IV route.

The primary outcome of the study was total tramadol consumption at the end of 48 h post operatively. All the patients were observed for any inadvertent motor or sensory blockade, change in VAS score, temperature change, features of Horner’s syndrome - ipsilateral ptosis, miosis and chemosis at intervals of 5 min each up to 15 mins after SGB placement. Following SGB patients received a standard technique of general anaesthesia. Post operatively each patient received multi modal analgesia with IV paracetamol 1gm, diclofenac 75 mg and tramadol PCA. All patients were monitored postoperatively for MAP, PR, RR, VAS at rest, VAS on movement and tramadol consumption at the following time interval - 0, 2, 4, 6, 8, 12, 24, 36 and 48 h. Nausea and vomiting and side effects like shivering, pruritus were also noted during the study period. Patient satisfaction score was taken at 24 and 48 h. Observations were analysed statistically and the following inferences were drawn.

·         The total tramadol consumption at 0, 6 and at the end of 48 h was significantly reduced (p value 0.029, 0.008 and 0.003 respectively) in the SGBDex group as compared to SGBC group. The total tramadol consumption at the end of 48 h was significantly reduced in SGBDex group as compared to SGBIV group (p value 0.003).

·         No patient in SGBDEX required tramadol PCA after 4 h post operatively. In SGBC, no patient required tramadol PCA after 12 h post operatively and in SGBIV, no patient required tramadol PCA after 8 h post operatively.

·         The postoperative VAS at rest was significantly reduced at 0, 2, 6, 12, 36 and 48 h (p values = 0.014, 0.013, 0.018, 0.023, 0.017 and 0.005 respectively) in the SGBDex as compared to the SGBC group and the postoperative VAS at rest was significantly reduced at 2 h in the SGBDex group as compared to the SGBIV group ( p value 0.006).

·         The postoperative VAS on movement was significantly reduced at 0, 2, 6, 12, 24 and 48 h (p values = 0.040, 0.022, 0.050, 0.043, 0.005 and 0.034 respectively) in the SGBDex group as compared to the SGBC group.

·         The hemodynamic parameters were within normal physiological range for most of the time intervals in all the three groups.

·         Only three patients reported transient nausea and none of the patients reported      vomiting, pruritus or shivering.

·         Patients reported superior patient satisfaction score at 24 and 48 h (p values = 0.002 and 0.004 respectively) in SGBDex as compared to the SGBC and SGBIV.

·         No serious adverse effects were reported in any patient during the entire study period.


CONCLUSION

Perineural dexamethasone with lignocaine in SGB significantly reduced tramadol consumption at 48 h post operatively as compared to IV dexamethasone and control group.


 
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