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

NCT04294732 | Completed Phase 4

• 1 other identifier: HZLEZGCFCANLEKR
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Postoperative third month

Secondary Outcomes (6)

• Investigate the pain relief activity of different concentrations within thirty-six hours

  Postoperative 12th hour.

• Investigate the pain relief activity of different concentrations within thirty-six hours

  Postoperative 24th hour

• Investigate the pain relief activity of different concentrations within thirty-six hours

  Postoperative 36th hour

• Investigate the pain relief activity of different concentrations within three months

  Postoperative first month

• Investigate the pain relief activity of different concentrations within three months

  Postoperative second month

Study Arms (3)

Only spinal anesthesia

PLACEBO COMPARATOR

Only spinal anesthesia without peripheral nerve block

Drug: Only spinal anesthesia without peripheral nerve block

high concentration

ACTIVE COMPARATOR

8 ml saline with 8 ml bupivacaine

Drug: Bupivacaine

low concentration

EXPERIMENTAL

8 ml bupivacaine with 16 ml of saline

Drug: Bupivacaine

Interventions

Bupivacaine 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.

Also known as: Saline

high concentration; low concentration

Only spinal anesthesia without peripheral nerve block DRUG

Only spinal anesthesia without peripheral nerve block

Only spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Hazal Ezgi Çifci

Izmir, Eyalet/Yerleşke, 35500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Hazal Ezgi Çifci

Model Details: 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

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: March 4, 2020
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

TU (1)