Efficacy of Popliteal Block & Bupivacaine Concentration Used for Analgesia

Status Completed

Clinical Trial Summary

In the orthopedic foot and ankle surgeries, the effects of postoperative popliteal nerve block applied for palliation of pain and local anesthetic agent in two different concentrations (0.166 and 0.250) which were used in popliteal nerve block procedure, will be investigated.

Clinical Trial Description

USG guided popliteal nerve block known to be effective in postoperative pain management in foot and ankle surgical procedures but clinical use of the procedure is not yet widespread. However, the volume and concentration of local anesthetic drugs to be administered is still controversial. The study was designed to be prospective and randomized. Patients will be divided into 3 groups by simple randomization. The results of power analysis (G-power 3.1) revealed that a total of 60 patients were required to be included in the study. Because of that, approximately 20 patients are planned for each group. Spinal anesthesia will be performed in all three groups. During procedure 8 ml saline with 8 ml bupivacaine will be apply to the first group and 8 ml bupivacaine and 16 ml of saline will be apply to the second group. Only spinal anesthesia will be given to the third group without peripheral nerve block. The patients participating in the study will not be informed about which group they belong to, the person who makes the block will not prepare the drug and the person who makes the block, the patient and the nurse will not know which concentration drug applied to which patient. Between two groups duration of motor block, duration of sensory block, post-op analgesia time, mobilization time will be investigate. Also the first pain time, the opioid requirement and opioid dose used will be investigated. Analgesia, duration of analgesia, time and requirement of administered IV analgesics, mobilization time after popliteal nerve block will be investigate. package statistical program SPSS (Statistical Package for Social Sciences version 18) will be used for statistical analysis. The parametrical values from the descriptive values will be given as mean and standard deviation, the non-parametric values will be given as number and percentage or median and min-max value. The suitability of the data to the normal distribution will be evaluated with the Kolmogorov-Smirnov test. One-way ANOVA will be use for the comparison of the quantitative data which is appropriate to the normal distribution. The Tukey HSD test will be used to identify the group that caused the difference. Kruskal Wallis-H test will be used to compare quantitative parameters that do not show normal distribution. Mann Whitney U test will be applied to determine the cause of the difference and chi-square test will be used to compare qualitative data. For the analyzes, the level of significance in the 95% confidence interval was found in p < 0.05. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04294732
Study type	Interventional
Source	Bozyaka Training and Research Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	April 1, 2018
Completion date	January 1, 2020

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See also
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Completed	`NCT02374008` - The Analgesic Effect of Combined Nerve Block and Systemic High Dose Glucocorticoid After Total Knee Arthroplasty.	Phase 4
Withdrawn	`NCT01625208` - Supraclavicular Versus Combined Block for Ulnar and Median Distribution Hand Surgery	N/A
Completed	`NCT06155903` - Peripheral Nerve Block vs Spinal Anesthesia in Patients With Femur Fracture	N/A
Terminated	`NCT05190302` - Determination of the Sensitivity, Specificity & Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During US Guided PNB
Terminated	`NCT02161484` - Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement	N/A
Active, not recruiting	`NCT06357013` - Postoperative Analgesia in Bilateral Knee Arthroplasties
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Withdrawn	`NCT04539730` - Liposomal Bupivacaine in Adductor Canal Blocks (ACB)	Phase 4
Withdrawn	`NCT03385967` - Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block	Phase 4
Completed	`NCT03069677` - Music vs Midazolam During Preop Nerve Block Placement	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of Popliteal Block and Bupivacaine Concentration Used for Analgesia in Foot and Ankle Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms