Infraclavicular Block Properties in Diabetic Patients
Condition: Diabetes Mellitus; Nerve Block Duration; Pain, Postoperative
MeSH terms: Diabetes Mellitus; Pain, Postoperative
Study type: Observational

Summary: 
      Background and objectives: The investigators are performing this study to explore whether the
      presence of diabetes mellitus (DM) will affect the outcomes of infraclavicular brachial
      plexus blocks (ICBs) in patients undergoing elbow, forearm and hand surgery.

      The primary hypothesis is that the sensory block duration will be delaying in diabetic
      patients.

      Methods: Ethics committee approval has been obtained and after written informed consents, 60
      patients are planning to be enrolled to the study. Diabetic patients will be included in
      Group DM and non-diabetics are included in Group NODM. All patients will receive
      ultrasound-guided ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Our
      primary outcome is sensory block duration, and secondary outcomes are sensory and motor block
      onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS)

      ≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the
      postoperative first 2 days. All outcomes will be assessed by blind investigators.
    

Detailed description: 
      Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral
      nerve blocks need to be investigated on human models, besides animal researches. The
      investigators have been performing this study to explore whether the presence of DM will
      affect the outcomes of infraclavicular brachial plexus blocks (ICBs) in patients undergoing
      elbow, forearm, and hand surgery. The primary hypothesis is that the sensory block duration
      will be delaying in diabetic patients.

      Methods: After obtaining ethics committee approval and written informed consent, 60 patients
      with American Society of Anesthesiologists (ASA) physical status I-IV and aged between 40 and
      80 years are enrolled to the study. Diabetic patients will be included in Group DM and
      non-diabetics will be included in Group NODM. All patients will receive ultrasound-guided
      ICBs with the mixture of 15 mL lidocaine 2% and 15 mL bupivacaine 0.5%. Postoperatively,
      patients will be administered diclomec SR 75 mg IM first and if still needed tramadol 100 mg
      IV as rescue analgesics (numeric rating scale (NRS) is ≥4). Our primary outcome is sensory
      block duration, and secondary outcomes are sensory and motor block onset times, motor block
      duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores, and
      rescue analgesic consumption through the postoperative first 2 days. All outcomes will be
      assessed by blind investigators.
    

Intervention name(s): Infraclavicular Brachial Plexus Blocks; Infraclavicular Brachial Plexus Blocks
Intervention type(s): Drug; Drug
Intervention description(s): All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Diabetic patients.; All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Nondiabetic patients.
Other intervention name(s): Same interventions, drugs and concentrations; Same interventions, drugs and concentrations
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for arm, elbow, forearm, and hand surgery.
      
Keywords: Diabetes mellitus; Infraclavicular brachial plexus block; Block duration; Time-to-first pain; Postoperative analgesia