Surgery to the Distal One Third of the Upper Limb Clinical Trial
Official title:
The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
| Verified date | November 2019 |
| Source | Mansoura University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Despite PH adjustment of local anesthetic solution improves the quality of the block in all
respects with special advantage of early onset of sensory and motor block, adequate level of
analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should
have the same effect which have not been evaluated on supraclavicular plexus block for upper
limb surgery.
The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor
block onset and prolong the duration of analgesia when compared to bupivacaine at operating
room temperature.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | September 17, 2018 |
| Est. primary completion date | June 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists physical class I or II Exclusion Criteria: - Patient refusal. - Pregnancy - Neuromuscular diseases (as myopathies, myasthenia gravies…) - Hematological diseases - Bleeding disorders - 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. - Bilateral upper limb injury to be performed at the same procedure. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Mansoura University, Faculty of Medicine | Mansourah | DK |
| Lead Sponsor | Collaborator |
|---|---|
| Mansoura University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to onset of sensory block | defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1) | for 30 min following injection | |
| Secondary | Time to onset of motor block | defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves. | For 3 hours after the injection of local anesthetic | |
| Secondary | Heart rate | For 3 hours after the injection of local anesthetic | ||
| Secondary | Blood pressure | For 3 hours after the injection of local anesthetic | ||
| Secondary | oxygen saturation in the peripheral blood | For 3 hours after the injection of local anesthetic | ||
| Secondary | Duration of sensory block | defined as the interval between end of injection and complete end of sensory block (score=2) | For 24 hours after the injection of local anesthetic | |
| Secondary | Duration of motor block | defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively. | For 24 hours after the injection of local anesthetic | |
| Secondary | The severity of postoperative pain | will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain. | For 24 hours after the injection of local anesthetic | |
| Secondary | Time for first analgesic request | Time to the first receiving of rescue analgesic from the time of blockade | For 24 hours after the injection of local anesthetic | |
| Secondary | Total analgesics received | Cumulative use of rescue analgesics after performing the blockade | for 24 hrs after the injection of local anesthetic | |
| Secondary | Satisfaction Score | Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor | for 48 hrs after the injection of local anesthetic |