Effect of Intraoperative Ankle Nerve Blocks on Postoperative Discharge in Patients Undergoing Orthopaedic Foot Surgery

NCT03550677 | Completed

• 1 other identifier: 49/07
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is an important clinical issue which negatively affects patient's satisfaction, delays discharge and repeated admission after discharge in orthopedic surgery. Peripheral nerve blocks are commonly used for postoperative analgesia as an adjunct to analgesic drugs. The aim of this study is to evaluate the effect of ankle blocks performed at the end of the surgery on postoperative discharge times, postoperativeanalgesia, patient's satisfaction, additional analgesic requirements, and complications in patients undergoing orthopedic foot surgery.

Conditions

Operative Incision

Keywords

Ankle nerve block; post operative analgesia; patient satisfaction; foot surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Postoperative pain is evaluated using Visual Analogue Scale.

  3 months

Secondary Outcomes (1)

• postoperative discharge times

  3 months

Study Arms (2)

Group General Anesthesia

EXPERIMENTAL

These group patients will be monitored with ECG, pulse oximetry and noninvasive blood pressure. Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10 mg-20 mg rocuronium and a proper size laryngeal mask airway will be placed to secure the airway. The lungs will be ventilated with a mixture of 50% and 50% oxygen.

Procedure: general anesthesia

Group Ankle Block

EXPERIMENTAL

These group patients will be monitored with ECG, pulse oximetry and noninvasive blood pressure. Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10 mg-20 mg rocuronium and a proper size laryngeal mask airway will be placed to secure the airway. The lungs will be ventilated with a mixture of 50% and 50% oxygen. After than an ankle block will be performed in patient group block patients using a mixture of 5 ml of 2% lidocaine and 10 ml of 0.5 bupivacaine the same amount placebo (saline) in group placebo under the guidance of peripheral nerve stimulator then the anesthesia will be disconnected and LMA will be removed. The patients will be transferred from postoperative care unit toward after they are eligible for discharge according to the modified scoring system.

Procedure: general anesthesia; Procedure: ankle block

Interventions

general anesthesia PROCEDURE

The patient will be monitored with ECG, pulse oximetry and noninvasive blood pressure. Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10-20 mg rocuronium and proper size Laryngeal mask airway will be placed securely the airway.

Also known as: Laryngeal mask airway

Group Ankle Block; Group General Anesthesia

ankle block PROCEDURE

ankle nerve block will be performed in group ankle block patients using a mixture of 5 ml of 2% lidocaine and 10 ml of 0.5% bupivacaine and same amount placebo (saline) in groups placebo under the guidance of peripheral nerve stimulator the anesthesia will be discontinued and LMA will be removed. The patients will be transferred from postoperative care unit to the ward after they are eligible for discharge according to modified Aldrete scoring system.

Group Ankle Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's acceptance,
• American Society of Anesthesiologists physical status I-III
• elective orthopedic foot surgery
• general anesthesia

You may not qualify if:

• Pregnancy
• history of chronic pain therapy
• hypersensitivity to study drugs
• allergy to study drugs
• blood coagulation disorder
• anticoagulant use

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Ankara, Altındag, 06110, Turkey (Türkiye)

Location

Related Publications (2)

• McLeod DH, Wong DH, Vaghadia H, Claridge RJ, Merrick PM. Lateral popliteal sciatic nerve block compared with ankle block for analgesia following foot surgery. Can J Anaesth. 1995 Sep;42(9):765-9. doi: 10.1007/BF03011173.

  PMID: 7497554 BACKGROUND

• Fraser TW, Doty JF. Peripheral Nerve Blocks in Foot and Ankle Surgery. Orthop Clin North Am. 2017 Oct;48(4):507-515. doi: 10.1016/j.ocl.2017.06.008. Epub 2017 Aug 16.

  PMID: 28870310 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Patient Satisfaction

Interventions

Anesthesia, General; Laryngeal Masks

Condition Hierarchy (Ancestors)

Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ceyda Ozhan Caparlar

  University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 20, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

TU (1)