CLONIDINE AS AN ADJUVANT TO ROPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK
- Conditions
- PATIENTS PLANNED FOR UPPER LIMB ORTHOPEDIC SURGERY
- Registration Number
- CTRI/2015/10/006321
- Lead Sponsor
- Government Medical College Bhavnagar
- Brief Summary
**Backgroundand Objectives:**
To evaluate the efficacy and safety of Clonidine as anadjuvant to Ropivacaine in supraclavicular brachial plexus blockade in respectto,
1. Onset, peak and durationof sensory blockade.
2. Onset, peak and durationof motor blockade.
3. Duration of effectivepost-operative analgesia.
4. Total dose and frequencyof rescue analgesics required in 24 hours.
5. Sedation score.
6. Effects on hemodynamicvariables- Heart Rate (HR), Mean Arterial Blood pressure (MAP) and peripheraloxygen saturation (SpO2).
7. Complications if any.
**Methods:**
After Approval from Institutionalreview board and informed written consent from the patients, this prospective,randomized, double blind controlled clinical study was carried out in 120patients of ASA physical status I and II, aged 20 – 60 years of either sexscheduled for upper limb orthopedic surgeries.
Patients were randomized to one of thetwo groups by sealed envelope method.
Group R(n = 60) – Ropivacaine 0.5% 30 cc + 0.6 cc normal saline
Group RC (n =60) –Ropivacaine 0.5%30 cc+ 0.6 cc (90 μg) clonidine
Monitoring consisting of heart rate,mean arterial blood pressure and peripheral oxygen saturation was establishedand baseline vital parameters were recorded.
After securing intravenous line,supraclavicular brachial plexus block was performed with the aid of nervelocator. Patients were observed for onset, peak and duration of sensory andmotor brachial plexus blockade. Changes in visual analogue score (VAS) werenoted and the first rescue analgesic was injected when VAS exceeded 5. The timefor first rescue analgesic required and the total number of rescue analgesicdoses injected in 24 hours was also noted in both the groups.
Changes in HR, BP, Sedation Score andSpO2 were also recorded as per the specified time.
**Results:**
Mean time of onset of sensoryblockade was 11.36±2.42 min and 9.84±1.58 min respectively in groups R and RC.Henceforth, the onset of sensory blockade was significantly earlier in group RCas compared to group R. (p=0.0001)
Mean time to achieve peak of sensoryblockade was 18.18±3.47 and 13.78±1.94minutes respectively in group R and RC. Henceforth, the time to achieve peak ofsensory blockade was significantly earlier in group RC as compared to group R. (P<0.0001)
Mean duration of sensory blockade was 477.00±29.77 and 678.42±104.07minutes respectively in groups R and RC. Henceforth, the durationof sensory blockade was significantlyprolonged in group RC as compared to group R. (P<0.0001)
The duration of analgesia wasprolonged with addition of clonidine to ropivacaine. Mean duration of analgesiawas 584.6±34.41 and 801±80.46 minutes respectively in groups R and RC.Henceforth, the duration of analgesia was significantly prolonged in group RCas compared to group R. (P<0.0001)
In group R, majority of patientsneeded minimum of two analgesic doses during 24 hour study period while ingroup RC, majority of patients needed only one analgesic dose.
**Hence, clonidine as an adjuvant to ropivacaineprovided significantly earlier onset and peak and prolonged duration of sensoryblockade and analgesia as compared to control group.**
Similar findings were noted formotor characteristics of supraclavicular brachial blockade in the present study.Mean time of onset was16.26±3.80and 14.5±2.36 min respectively in group R and group RC (p=0.0094), peak was 37.56±3.03and 22.85±3.94 min respectively in group R and group RC (p<0.0001) and duration of motor blockade was 417.20±35.343 and 547.80±34.184 minrespectively in group R and group RC which was statistically significant.(P<0.0001) Henceforth, theonset and peak of motor blockade was significantly earlier and duration wassignificantly prolonged in groups RC as compared to group R.
**Hence, clonidine as an adjuvantto ropivacaine provided significantly earlier onset and peak and prolongedduration of motor blockade as compared to control group.**
In this study, sedation score was higher in group RC (score2) as compared to group R (score 0) without any adverse consequences. (P<0.05)
On comparison of hemodynamics amongstthe two groups, there was statistically significant decrease in HR and BP ingroup RC as compared to group R. Two patients developed bradycardia in group RC,which responded to Inj.atropine and was not clinically significant.
SpO2remained stable and comparable in both groups throughout the studyperiod. (P>0.05)
Except bradycardia (3% in group RC), noother complication was observed in two groups.
**Conclusion:**
Fromthis study, it is concluded that addition of 90 μg of clonidine to ropivacainein supraclavicular brachial plexus blockade is safe and effective in improvingthe quality of blockade, prolongs the duration and provides effective analgesiawith adequate sedation well extending into the postoperative period without anyadverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
- Inclusion Criteria •Age: 20 to 60 years.
- •Gender: Either gender.
- •Patients scheduled for elective upper limb orthopedic surgery •ASA physical status II and I.
- •BMI ≤ 25kg/m2.
- •Informed written consent for participation in study.
- Exclusion Criteria •Patients refusing consent.
- •Contraindications to regional anesthesia.
- •Previous nerve injury.
- •History of drug dependence/abuse.
- •History of drug allergy.
- •Patients on anticoagulants.
- •History of bleeding disorders.
- •Any major systemic illness.
- •Antenatal females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SENSORY AND MOTOTR CHARECTERISTICS- ONSET, PEAK, DURATION End of the injection was taken as Time 0. Immediately after the block, sensory and motor characteristics of blockade were assessed at 1, 3, 5, 10, 15, 30 minutes and then at hourly interval till offset of sensory and motor blockade and then at two hourly interval for 24 hours.
- Secondary Outcome Measures
Name Time Method Duration of effective post-operative analgesia. Total dose and frequency of rescue analgesics required in 24 hours
Trial Locations
- Locations (1)
GOVERNMENT MEDICAL COLLEGE AND SIR T. HOSPITAL, BHAVNAGAR
🇮🇳Bhavnagar, GUJARAT, India
GOVERNMENT MEDICAL COLLEGE AND SIR T. HOSPITAL, BHAVNAGAR🇮🇳Bhavnagar, GUJARAT, IndiaDrVatsal ZanzmeraPrincipal investigator9601291762vatsal.zanzmera@gmail.com