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

March 2, 2020 updated by: Hazal Ezgi Çifci, Bozyaka Training and Research Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • İzmir, Eyalet/Yerleşke, Turkey, 35500
        • Hazal Ezgi Çifci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Only spinal anesthesia
Only spinal anesthesia without peripheral nerve block
Drug: Only spinal anesthesia without peripheral nerve block
Only spinal anesthesia without peripheral nerve block
Active Comparator: high concentration
8 ml saline with 8 ml bupivacaine
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.

Other Names:
  • Saline
Experimental: low concentration
8 ml bupivacaine with 16 ml of saline
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.

Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain relief activity of popliteal nerve block within thirty-six hours
Time Frame: Postoperative 12th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative 12th hour
pain relief activity of popliteal nerve block within thirty-six hours
Time Frame: Postoperative 24th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative 24th hour
pain relief activity of popliteal nerve block within thirty-six hours
Time Frame: Postoperative 36th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative 36th hour
pain relief activity of popliteal nerve block within three months
Time Frame: Postoperative first month
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative first month
pain relief activity of popliteal nerve block within three months
Time Frame: Postoperative second month
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. İf the numeric rating scale is above 3, it will be considered as pain. İf pain persist over 1 month, ıt will be considered as chronic pain.
Postoperative second month
pain relief activity of popliteal nerve block within three months
Time Frame: Postoperative third month
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. İf the numeric rating scale is above 3, it will be considered as pain. İf pain persist over 1 month, ıt will be considered as chronic pain.
Postoperative third month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigate the pain relief activity of different concentrations within thirty-six hours
Time Frame: Postoperative 12th hour.
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative 12th hour.
Investigate the pain relief activity of different concentrations within thirty-six hours
Time Frame: Postoperative 24th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative 24th hour
Investigate the pain relief activity of different concentrations within thirty-six hours
Time Frame: Postoperative 36th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative 36th hour
Investigate the pain relief activity of different concentrations within three months
Time Frame: Postoperative first month
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. İf the numeric rating scale is above 3, it will be considered as pain.
Postoperative first month
Investigate the pain relief activity of different concentrations within three months
Time Frame: Postoperative second month
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. İf the numeric rating scale is above 3, it will be considered as pain. İf pain persist over 1 month, ıt will be considered as chronic pain.
Postoperative second month
Investigate the pain relief activity of different concentrations within three months
Time Frame: Postoperative third month
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. İf the numeric rating scale is above 3, it will be considered as pain. İf pain persist over 1 month, ıt will be considered as chronic pain.
Postoperative third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bozyaka Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HZLEZGCFCANLEKR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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