Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia
Study Details
Study Description
Brief Summary
Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a antiinflammatory steroid. Although the perineural administration is off-label, several studies recognised its analgetic action as an adjuvant for peripheral nerves blockade, permitting to reduce the concentration of the local anesthetics and extending the sensory and motor block.Questions remain concerning the mechanism of action, optimal dose, the lack/degree of toxicity and the comparison with intravenous administration.The aim of this prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
The investigators conducted a prospective randomized controlled study in 150 patients American Society of Anesthesiologists (ASA) score I-III scheduled for upper limb surgery , divided in 3 groups: group A received anesthesia VIB block with ropivacaine 0,5% 100 mg +lidocaine 1%+1 ml saline; group B received VIB block with ropivacaine 0,5% 100 mg +lidocaine 1% + 2 mg dexamethasone; group C received ropivacaine 0,5% 100 mg +lidocaine 1% + 4 mg dexamethasone.The anesthesiologist may use the ultrasound for visual guidance, but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.
Intraoperative sedation was provided with intermittent bolus 10-20 mg IV Propofol. Postoperatively all patients received the same analgetic protocol when Visual Analog Pain Scale (VAS) over 3 with IV Perfalgan and Lornoxicam 8 mg/12 hours for 24 hours. If after 30 minutes VAS is still over 3, a loading dose of morphine 0,05 mg/kg should be administered. At first analgetic request, the nurse conducts an ice-probe test to both arms and will note the answer: same cold, slightly burn, burn, aching with the reason to test the potentially hyperalgesia effect related to ropivacaine. The data recorded are: time to first analgetic use, VAS at block regression, ice-probe test, motor and sensitive block duration, glycemic variations at 4 h, neurological complications immediately after block, total morphine consumption.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Group A VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request. |
Drug: Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Names:
Drug: Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Names:
Drug: Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
|
| Active Comparator: Group B VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request. |
Drug: Dexamethasone
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
Drug: Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Names:
Drug: Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Names:
Drug: Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
|
| Active Comparator: Group C VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.05 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request. |
Drug: Dexamethasone
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
Drug: Ropivacaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
Drug: Paracetamol
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Names:
Drug: Morphine
After the block regression, at the first analgetic request the patients received the same analgesia protocol
Other Names:
Drug: Lidocaine
One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sensory block duration [First 24 hours]
The time in minutes measured between VIB block to first analgetic request
Secondary Outcome Measures
- Motor block duration [First 24 hours postoperatively]
The time in minutes measured between VIB block to complete movement of the hand
- Glycemic variations at 4 hours post-VIB block [First 4 hours postoperatively]
Determination of blood sugar level
- Number of patients opioid free analgesia [First 24 hours postoperatively]
Number of reported patients with no need opioid analgesia
- VAS at the block regression [First 24 hours postoperatively]
VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible )
- Cutaneous temperature ice-probe [First 24 hours postoperatively]
The cold sensation on ice-probe test to both arms could be the same or burn likely
- Total morphine consumption at 24 hours [First 24 hours postoperatively]
Cumulative morphine administration in milligrams
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ASA I-III,
-
BMI<40,
-
non-anemic
Exclusion Criteria:
- High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foisor Orthopedic Clinical Hospital | Bucharest | Romania | 021383 |
Sponsors and Collaborators
- Foisor Orthopedics Clinical Hospital
Investigators
- Study Director: Ioan Cristian Stoica, MD Prof, Foisor Orthopedics Clinical Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID AN-002-14