Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine
- Conditions
- Shoulder Pain
- Interventions
- Registration Number
- NCT04284007
- Lead Sponsor
- Mansoura University
- Brief Summary
Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
- Detailed Description
Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks.
The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.
The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- American Society of Anesthesiologists physical status grade I and grade II.
- Patient refusal.
- Neuromuscular diseases (as myopathies, myasthenia gravies, ......)
- Hematological diseases, bleeding or coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
- Sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2
- contralateral phrenic palsy
- pneumothorax
- pneumectomy
- severe COPD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Perineural dexamethasone in addition to levobupivacaine Perineural dexamethasone in addition to levobupivacaine Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline. Perineural levobupivacaine with intravenous saline Perineural levobupivacaine Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline. Intravenous dexamethasone with perineural levobupivacaine Intravenous dexamethasone with perineural levobupivacaine Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone.
- Primary Outcome Measures
Name Time Method Duration of postoperative analgesia for 24 hour postoperatively as measured by time to first analgesic requirement.
- Secondary Outcome Measures
Name Time Method Onset time of motor block For 30 min after injecting local anesthic Motor block will be determined according to the modified Bromage scale:
* Grade 0 = Normal motor function with full flexion and extention of elbow.
* Grade 1 = Decrease motor power.
* Grade 2 = Complete motor block. Onset time of motor block will be defined as the time interval between end of local anaesthetic administration and complete motor block (grade 2).Postoperative peripheral oxygen saturation changes For one hour after admission to the postoperative anesthesia care unit Postoperative heart rate changes For one hour after admission to the postoperative anesthesia care unit Intraoperative Heart rate changes For 3 hours after surgery Heart rate changes
Duration of sensory block within 24 hours after the surgery. defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0)
Duration of motor block within 24 hours after the surge defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0).
Intraoperative analgesic consumption For 3 hours after surgery the intraoperative analgesic dose consumption would be calculated The investigators can use fentanyl as analgesic if the patient required during the surgery ( 50-100 mic)
Intraoperative Mean arterial blood pressure changes For 3 hours after surgery Mean arterial blood pressure changes
Postoperative Mean arterial blood pressure changes For one hour after admission to the postoperative anesthesia care unit Onset of Sensory block For 30 min after injecting local anesthetic Patients will be closely observed until 30 minutes after the end of local anesthetic injection. Block success will be defined as loss of sensation to pinprick in the C4 and C5 sensory dermatome distribution measured 30 minutes after the end of local anesthetic injection. sensory block will be assessed by pin prick test using a 3point scale: • Grade 0 = Normal sensation.
* Grade 1 = loss of sensation to pin prick (analgesia).
* Grade 2 = loss of sensation to touch (anaesthesia). Onset time for sensory block will be defined as the time interval between the end of local anaesthesia administration and complete sensory block (score 2).Total analgesic need and the onset of first intravenous analgesia After transportation of the patient from PACU up to 24 hours postoperative. Total analgesic need to rescue analgesic (pethidine) calculated by mg. And the onset of time for first intravenous analgesia during the 24 hours postoperative by hours.
Patient satisfaction: 2-point scale first 24 hours postoperatively concerning the procedure is assessed using a 2-point scale (1= satisfied, I would want the same anesthesia / analgesia method for the next surgery, 2= unsatisfied, I would want a different anesthesia / analgesia method for the next surgery).
Pain score Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours. The VAS is represented with straight line with one end has the anchor " no pain" and it takes 0, while the other end of the line has the anchor " pain as bad as it could be" and it takes 10.
The patient will receive the rescue analgesic when the score is more than 4)
Trial Locations
- Locations (1)
Mansoura University
🇪🇬Mansourah, Dakhlia, Egypt