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.
- Conditions
- Injury, poisoning and certain other consequences of external causes,
- Registration Number
- CTRI/2017/02/007851
- Lead Sponsor
- Department of Anaesthesia
- Brief Summary
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 ofaddition of dexamethasone to lignocaine during preoperative SGB or IV withcontrol in upper limb surgeries.Therefore the present study was planned toevaluate the tramadol sparing effect of addition of dexamethasone to lignocaineduring 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 studywas a prospective, randomised, double blind, placebo controlled clinical trialwhich 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 ofdexamethasone as an adjuvant to lignocaine in pre operative SGB in patientsundergoing upper limb surgeries.
Fifty sevenpatients (19 per group) of ASA grade I-II, aged 18-60 years of either sexhaving BMI 18-30 kg.m-2 scheduled to undergo upper limb orthopaedicsurgery under general anaesthesia were enrolled in the study after takingwritten informed consent.
A preoperativeSGB was given in all the patients. Using a para-tracheal out of plane technique(between thyroid gland and common carotid artery), a blunt regional anaesthesianeedle (22G, 50mm Stimuplex A; BBraun, Melsung, Germany) was advanced afterretracting the carotid artery laterally and directing towards the longus collimuscle. Following which 4 ml of study drug per group allocation was given subfascially.
**SGBDex**(n = 19) received preoperative ultrasound guided SGB with 4 ml of a solution (3ml 2% lignocaine + 1 ml dexamethasone (4mg) = final volume of 4 ml) and 15 mlof normal saline by IV route.
**SGBC**(n = 19) received preoperativeultrasound guided SGB with 4 ml of a solution (3 ml 2% lignocaine + 1 ml normalsaline = final volume of 4 ml) and 15 ml of normal saline by IV route.
**SGBIV** (n = 19) received preoperative ultrasound guidedSGB with 4 ml of a solution (3 ml 2% lignocaine + 1 ml normal saline = finalvolume of 4 ml) and 1 ml dexamethasone (4mg) diluted in 15 ml of normal salineby IV route.
The primary outcome of thestudy was total tramadol consumption at the end of 48 h post operatively. Allthe 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 15mins after SGB placement. Following SGB patients received a standard techniqueof general anaesthesia. Post operatively each patient received multi modalanalgesia with IV paracetamol 1gm, diclofenac 75 mg and tramadol PCA. Allpatients were monitored postoperatively for MAP, PR, RR, VAS at rest, VAS onmovement and tramadol consumption at thefollowing time interval - 0, 2, 4, 6, 8, 12, 24, 36 and 48 h. Nausea andvomiting and side effects like shivering, pruritus were also noted during thestudy period. Patient satisfaction score was taken at 24 and 48 h. Observationswere analysed statistically and the following inferences were drawn.
· The total tramadol consumption at 0, 6 and atthe end of 48 h was significantly reduced (p value 0.029, 0.008 and 0.003 respectively) in the SGBDex group ascompared to SGBC group. The total tramadol consumption at the end of48 h was significantly reduced in SGBDex groupascompared to SGBIV group (p value 0.003).
· No patient in SGBDEX requiredtramadol PCA after 4 h post operatively. In SGBC, no patientrequired tramadol PCA after 12 h post operatively and in SGBIV, nopatient required tramadol PCA after 8 h post operatively.
· The postoperative VAS at rest was significantlyreduced 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 theSGBC group and the postoperative VAS at rest was significantlyreduced at 2 h in the SGBDex group as compared to the SGBIVgroup ( p value 0.006).
· The postoperative VAS on movement wassignificantly 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 SGBDexgroup as compared to the SGBC group.
· The hemodynamic parameters were within normalphysiological range for most of the time intervals in all the three groups.
· Only three patients reported transient nauseaand none of the patients reported vomiting, pruritus or shivering.
· Patients reported superior patient satisfactionscore at 24 and 48 h (p values = 0.002 and 0.004 respectively) in SGBDex as compared to the SGBCand SGBIV.
· No serious adverse effects were reported in anypatient during the entire study period.
**CONCLUSION**
Perineural dexamethasonewith lignocaine in SGB significantly reduced tramadol consumption at 48 h postoperatively as compared to IV dexamethasone and control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 57
- 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.
- Patient’s refusal for the procedure.
- Patients having history of substance abuse.
- Patients with coagulopathy and bleeding disorders.
- Pre existing peripheral neuropathy.
- Pregnant and lactating women.
- Patients having inability to use PCA pump.
- Contraindication to study drug lignocaine, dexamethasone and tramadol.
- 10.Patients with simultaneous acute post operative pain in other parts of the body.
- Contraindication to general anaesthesia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of Anaesthesia, GMCH 32, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Department of Anaesthesia, GMCH 32, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaProf Deepak ThapaPrincipal investigator09646121524dpkthapa@gmail.com