Clinical trial NCT04294732: Efficacy of Popliteal Block and Bupivacaine Concentration Used for Analgesia in Foot and Ankle Surgery
Official title: Efficacy of Popliteal Block and Bupivacaine Concentration Used for Analgesia in Foot and Ankle Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot and Ankle Surgery
Popliteal Nerve Block
Peripheral Nerve Block
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing orthopedic surgery on foot and ankle and who agreed to participate in the study

Exclusion Criteria:

* Patients with sensitivity to local anesthetic
* Patients who do not want to be included in the study
* Preoperative mobilization and movement limitation
* Patients who are not co-operate, cannot complete questionnaire forms and inquiry forms
* Patients with skin infection at the injection site
* Patients with diabetic neuropathy
* Patients with bleeding disorder / Coagulopathy
* Pregnancy

Primary outcomes:
measure: pain relief activity of popliteal nerve block within thirty-six hours
timeFrame: Postoperative 12th hour
measure: pain relief activity of popliteal nerve block within thirty-six hours
timeFrame: Postoperative 24th hour
measure: pain relief activity of popliteal nerve block within thirty-six hours
timeFrame: Postoperative 36th hour
measure: pain relief activity of popliteal nerve block within three months
timeFrame: Postoperative first month
measure: pain relief activity of popliteal nerve block within three months
timeFrame: Postoperative second month
measure: pain relief activity of popliteal nerve block within three months
timeFrame: Postoperative third month
Secondary outcomes:
measure: Investigate the pain relief activity of different concentrations within thirty-six hours
timeFrame: Postoperative 12th hour.
measure: Investigate the pain relief activity of different concentrations within thirty-six hours
timeFrame: Postoperative 24th hour
measure: Investigate the pain relief activity of different concentrations within thirty-six hours
timeFrame: Postoperative 36th hour
measure: Investigate the pain relief activity of different concentrations within three months
timeFrame: Postoperative first month
measure: Investigate the pain relief activity of different concentrations within three months
timeFrame: Postoperative second month
measure: Investigate the pain relief activity of different concentrations within three months
timeFrame: Postoperative third month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Hazal Ezgi Çifci
state: Eyalet/Yerleşke
Study officials:
References: