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

Bozyaka Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Peripheral Nerve Block; Foot and Ankle Surgery; Popliteal Nerve Block

Treatments: Drug: Only spinal anesthesia without peripheral nerve block; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04294732

HZLEZGCFCANLEKR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 3 patient groups, including a placebo group

Only spinal anesthesia

Placebo Comparator group

Description:

Only spinal anesthesia without peripheral nerve block

Treatment:

Drug: Only spinal anesthesia without peripheral nerve block

high concentration

Active Comparator group

Description:

8 ml saline with 8 ml bupivacaine

Treatment:

Drug: Bupivacaine

low concentration

Experimental group

Description:

8 ml bupivacaine with 16 ml of saline

Treatment:

Drug: Bupivacaine