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

Primary Purpose

Operative Incision

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
general anesthesia
ankle block
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Operative Incision focused on measuring Ankle nerve block, post operative analgesia, patient satisfaction, foot surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group General Anesthesia

Group Ankle Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative pain
Postoperative pain is evaluated using Visual Analogue Scale.

Secondary Outcome Measures

postoperative discharge times
postoperative discharge times of paitnets after surgery

Full Information

First Posted
May 28, 2018
Last Updated
December 23, 2019
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03550677
Brief Title
Effect of Intraoperative Ankle Nerve Blocks on Postoperative Discharge in Patients Undergoing Orthopaedic Foot Surgery
Official Title
Effect of Intraoperative Ankle Nerve Blocks on Postoperative Discharge in Patients Undergoing Orthopaedic Foot Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
After written informed consent obtained from patients, patients will be randomly assigned to placebo group (Group I) and block group (group II) using sealed envelope method. IV venous catheter will be inserted and saline or Ringer's Lactate solution will be infused to patients for prehydration.0.1-0.5 mg/kg midazolam will be given for premedication. After arriving into OR, the 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 (LMA) will be placed to secure the airway. The lungs will be ventilated with a mixture of 50% air + 50% oxygen. Propofol and remifentanil based total intravenous anesthesia (TIVA) technique will be used for the maintenance of anesthesia. Tenoxicam 20 mg will be used for preemptive analgesia, cefazolin 25 mg/kg for antibiotic prophylaxis, ranitidine 50 mg for gastric protection, and metoclopramide 10 mg for postoperative nausea and vomiting. Acetaminophen 10-15 mg/kg IV will be given for postoperative analgesia at the time of wound closure. At the end of the operation, an ankle nerve block will be performed in group II patient using a mixture of 2%lidocaine and 10 ml of bupivacaine and the same amount placebo in group I (placebo group) 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 were eligible for discharge according to modified Aldrete scoring system. Postoperative analgesia will be evaluated by a study member who is blinded to study groups using visual analog scale (VAS). Acetaminophen 1000 mg p.o. were given at 8 hours intervals and an intravenous patient-controlled analgesia containing 3 mg/ml of tramadol will be used for postoperative pain therapy. Pethidine 0.5 mg/kg IV will be used for rescue analgesic if VAS score is greater than 3. The motor block will be evaluated using Bromage scale, sensorial block with pin-prick test. The duration of motor and sensorial block, postoperative VAS scores, the time to the first analgesic requirement, total analgesic consumption and vital parameters will be recorded. Patient's satisfaction will be evaluated using 3 point scale between the scores 0 and 2. 0= poor 1= fair 2=satisfied Postoperative discharge times will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operative Incision
Keywords
Ankle nerve block, post operative analgesia, patient satisfaction, foot surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group General Anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Ankle Block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
general anesthesia
Other Intervention Name(s)
Laryngeal mask airway
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ankle block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain is evaluated using Visual Analogue Scale.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
postoperative discharge times
Description
postoperative discharge times of paitnets after surgery
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient's acceptance, American Society of Anesthesiologists physical status I-III elective orthopedic foot surgery general anesthesia Exclusion Criteria: Pregnancy history of chronic pain therapy hypersensitivity to study drugs allergy to study drugs blood coagulation disorder anticoagulant use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ceyda Ozhan Caparlar
Organizational Affiliation
University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7497554
Citation
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. Erratum In: Can J Anaesth 1995 Nov;42(11):1065.
Results Reference
background
PubMed Identifier
28870310
Citation
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.
Results Reference
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Effect of Intraoperative Ankle Nerve Blocks on Postoperative Discharge in Patients Undergoing Orthopaedic Foot Surgery

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