Foot and Ankle SurgeryPhase 4NCT04294732

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

A Phase 4 study testing Bupivacaine and Only spinal anesthesia without peripheral nerve block in people with Foot and Ankle Surgery and Popliteal Nerve Block, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Foot and Ankle Surgery, Popliteal Nerve Block, Peripheral Nerve Block
What is being tested?: Bupivacaine and Only spinal anesthesia without peripheral nerve block
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Apr 2018to 1 Jan 2020
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hazal Ezgi Çifci
Izmir, Eyalet/Yerleşke, 35500

Other trials in Turkey (Türkiye)

About this study

Read the 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
Being tested: Bupivacaine, Only spinal anesthesia without peripheral nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacaineDrug
Also called Saline
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 blockDrug
Only spinal anesthesia without peripheral nerve block

Study groups in NCT04294732
Study group	Role	What they receive
Only spinal anesthesia	Placebo comparator	Only spinal anesthesia without peripheral nerve block Receives: Drug: Only spinal anesthesia without peripheral nerve block
high concentration	Active comparator	8 ml saline with 8 ml bupivacaine Receives: Drug: Bupivacaine
low concentration	Experimental	8 ml bupivacaine with 16 ml of saline Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative 12th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative 24th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative 36th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative first month
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. 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.
Measured: Postoperative second month
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. 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.
Measured: Postoperative third month

Secondary outcomes (6)

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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative 12th hour.
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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative 24th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative 36th hour
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. İf the numeric rating scale is above 3, it will be considered as pain.
Measured: Postoperative first month
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. 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.
Measured: Postoperative second month
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. 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.
Measured: Postoperative third month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20181 Jan 2020

First posted4 Mar 2020
Study start1 Apr 2018
Primary completion1 Apr 2019
Study completion1 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Foot and Ankle SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04294732
Sponsor's protocol ID: HZLEZGCFCANLEKR
Status last verified: Mar 2020
First submitted: 27 Sep 2018
Last updated: 4 Mar 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
Recruiting
Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery
Gastrocnemius, Ankle Surgery
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
Active, not recruitingEarly Phase 1
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Ankle Arthrodesis, MTP Arthrodesis
RecruitingPhase 4
Skin Preparation for Elective Foot and Ankle Surgery
Microbial Colonization, Foot and Ankle Disorders

All Foot and Ankle Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Popliteal Block and Bupivacaine Concentration Used for Analgesia in Foot and Ankle Surgery
ClinicalTrials.gov ID: NCT04294732
Acronym / sponsor ID: HZLEZGCFCANLEKR
Conditions: Foot and Ankle Surgery, Popliteal Nerve Block, Peripheral Nerve Block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Bozyaka Training and Research HospitalUniversity, hospital or other
Study start: 1 Apr 2018 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 1 Jan 2020 (actual)
First posted: 4 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
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

Arm	Type	Receives
Only spinal anesthesia	Placebo comparator	Drug: Only spinal anesthesia without peripheral nerve blockOnly spinal anesthesia without peripheral nerve block
high concentration	Active comparator	Drug: Bupivacaine8 ml saline with 8 ml bupivacaine
low concentration	Experimental	Drug: Bupivacaine8 ml bupivacaine with 16 ml of saline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BupivacaineAlso: Salinebupivacaine is a local anesthetic drug which is already using in surgical procedures. saline is isotonic solution of which has include %0,9 NACL.	Drug	high concentration, low concentration
Only spinal anesthesia without peripheral nerve blockOnly spinal anesthesia without peripheral nerve block	Drug	Only spinal anesthesia

Primary outcome

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.
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.
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.
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.
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.
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.

6 secondary outcomes

Investigate the pain relief activity of different concentrations within thirty-six hours
Time frame: Postoperative 12th hour.
Investigate the pain relief activity of different concentrations within thirty-six hours
Time frame: Postoperative 24th hour
Investigate the pain relief activity of different concentrations within thirty-six hours
Time frame: Postoperative 36th hour
Investigate the pain relief activity of different concentrations within three months
Time frame: Postoperative first month
Investigate the pain relief activity of different concentrations within three months
Time frame: Postoperative second month
Investigate the pain relief activity of different concentrations within three months
Time frame: Postoperative third month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Individual participant dataSharing planned: Undecided

Related trials for Foot and Ankle Surgery

RecruitingObservational study
Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery
Diabetic Foot Ulcer, Wound Healing
Recruiting
Efficacy of Gastrocnemius Plane Block for Foot and Ankle Surgery
Gastrocnemius, Ankle Surgery
Not yet recruitingPhase 4
Suzetrigine for Postoperative Pain After Total Ankle Replacement
Ankle Osteoarthritis, Postoperative Pain
Active, not recruitingEarly Phase 1
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Ankle Arthrodesis, MTP Arthrodesis
RecruitingPhase 4
Skin Preparation for Elective Foot and Ankle Surgery
Microbial Colonization, Foot and Ankle Disorders

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain relief activity of popliteal nerve block within thirty-six hours (time frame: Postoperative 12th hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04294732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.