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

Peripheral Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294732
• Other study ID #: HZLEZGCFCANLEKR
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2020
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 1, 2020
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.
• Only spinal anesthesia without peripheral nerve block
Only spinal anesthesia without peripheral nerve block

Locations

Country	Name	City	State
Turkey	Hazal Ezgi Çifci	Izmir	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain relief activity of popliteal nerve block within thirty-six hours	Numeric rating scale will be use for evaluate pain. Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at 12th hour. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative 12th hour
Primary	pain relief activity of popliteal nerve block within thirty-six hours	Numeric rating scale will be use for evaluate pain. Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at 24th hour. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative 24th hour
Primary	pain relief activity of popliteal nerve block within thirty-six hours	Numeric rating scale will be use for evaluate pain. Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at 36th hour. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative 36th hour
Primary	pain relief activity of popliteal nerve block within three months	Numeric rating scale will be use for evaluate pain. Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at first months. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative first month
Primary	pain relief activity of popliteal nerve block within three months	Numeric rating scale will be use for evaluate pain. Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at second months. If the numeric rating scale is above 3, it will be considered as pain. If pain persist over 1 month, it will be considered as chronic pain.	Postoperative second month
Primary	pain relief activity of popliteal nerve block within three months	Numeric rating scale will be use for evaluate pain. Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at third months. If the numeric rating scale is above 3, it will be considered as pain. If pain persist over 1 month, it will be considered as chronic pain.	Postoperative third month
Secondary	Investigate the pain relief activity of different concentrations within thirty-six hours	To compare the pain relief activity of bupivacaine at a concentration of 0.166 and 0.250 in popliteal block. Numeric rating scale will be use for evaluate pain Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at 12th hour. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative 12th hour.
Secondary	Investigate the pain relief activity of different concentrations within thirty-six hours	To compare the pain relief activity of bupivacaine at a concentration of 0.166 and 0.250 in popliteal block. Numeric rating scale will be use for evaluate pain Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at 24th hours. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative 24th hour
Secondary	Investigate the pain relief activity of different concentrations within thirty-six hours	To compare the pain relief activity of bupivacaine at a concentration of 0.166 and 0.250 in popliteal block. Numeric rating scale will be use for evaluate pain Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at 36th hours. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative 36th hour
Secondary	Investigate the pain relief activity of different concentrations within three months	To compare the pain relief activity of bupivacaine at a concentration of 0.166 and 0.250 in popliteal block. Numeric rating scale will be use for evaluate pain Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at first month. If the numeric rating scale is above 3, it will be considered as pain.	Postoperative first month
Secondary	Investigate the pain relief activity of different concentrations within three months	To compare the pain relief activity of bupivacaine at a concentration of 0.166 and 0.250 in popliteal block. Numeric rating scale will be use for evaluate pain Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at second month. If the numeric rating scale is above 3, it will be considered as pain. If pain persist over 1 month, it will be considered as chronic pain.	Postoperative second month
Secondary	Investigate the pain relief activity of different concentrations within three months	To compare the pain relief activity of bupivacaine at a concentration of 0.166 and 0.250 in popliteal block. Numeric rating scale will be use for evaluate pain Numeric rating scale contains 0 to 10 pain scores. 0 means no pain and 10 means maximum pain perception which is described by patient. Numeric rating scale will be apply to patient at third month. If the numeric rating scale is above 3, it will be considered as pain. If pain persist over 1 month, it will be considered as chronic pain.	Postoperative third month