A Phase 1 interventional study of Bupivacaine Hydrochloride 5 MG/ML in Effect Increased, sponsored by Erzurum Palandöken State Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by Erzurum Palandöken State Hospital · Phase 1, Interventional, and Treatment
Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.
The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study.
Patients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents.
The patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block.
Bupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2.
The block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist.
At the end of the ICBP block, an anesthetist blinded to the technique evaluated sensory and motor block in every minutes between 5th and 30th minutes as follows. The innervated areas (each dermatome) was evaluated using a pinprick test. The motor block was evaluated by bromage modified scale in every minutes between 10th and 30th minutes. Anxious patients were administered additional midazolam. Subjects refusing awake surgery were administered a propofol infusion with supplemental oxygen as necessary.
Erzurum Palandöken State Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine
Drug: Bupivacaine Hydrochloride 5 MG/ML
37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine
Drug: Bupivacaine Hydrochloride 5 MG/ML
Drug page: Bupivacaine
Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine
Evaluate sensory block's onset time
Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)
Time frame: 30 minutes after Brachial Plexus Block
Evaluate motor block's onset times
Motion on distal arm was evaluated by bromage scale (0- full flexion of distal arm, 3-unable to move distal arm)
Time frame: 30 minutes after Brachial Plexus Block
Plan to share: Undecided
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Studies of the drug tested here: Bupivacaine
Erzurum Palandöken State Hospital