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

NCT ID: NCT04294732

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-01-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Only spinal anesthesia

Only spinal anesthesia without peripheral nerve block

Group Type: PLACEBO_COMPARATOR

Only spinal anesthesia without peripheral nerve block

Intervention Type: DRUG

Only spinal anesthesia without peripheral nerve block

high concentration

8 ml saline with 8 ml bupivacaine

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

bupivacaine is a local anesthetic drug which is already using in surgical procedures.

saline is isotonic solution of which has include %0,9 NACL.

low concentration

8 ml bupivacaine with 16 ml of saline

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

bupivacaine is a local anesthetic drug which is already using in surgical procedures.

saline is isotonic solution of which has include %0,9 NACL.

Interventions

Bupivacaine

bupivacaine is a local anesthetic drug which is already using in surgical procedures.

saline is isotonic solution of which has include %0,9 NACL.

Intervention Type: DRUG

Only spinal anesthesia without peripheral nerve block

Only spinal anesthesia without peripheral nerve block

Intervention Type: DRUG

Other Intervention Names

Saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hazal Ezgi Çifci

Principal Investigator Hazal Ezgi Çifci

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hazal Ezgi Çifci

Izmir, Eyalet/Yerleşke, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HZLEZGCFCANLEKR

Identifier Type: -

Identifier Source: org_study_id