Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy


Original post, click here

Verified May 2017 by Jenna Walters, Vanderbilt University Medical Center

Sponsor:

Information provided by (Responsible Party):

Jenna Walters, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03173326

First received: May 29, 2017

Last updated: May 29, 2017

Last verified: May 2017

The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl.

Knee Arthroscopy
General Anesthesia
Subarachnoid Block
Procedure: General anesthesia
Procedure: Subarachnoid block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Evaluating Patient Satisfaction and Postoperative Analgesia Between Subarachnoid Block With 2-chloroprocaine Versus General Anesthesia for Knee Arthroscopy

Primary Outcome Measures:

  • Pain score [ Time Frame: Discharge from post anesthesia care unit (PACU) (usually one hour) ]

    Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.

  • Pain score [ Time Frame: Post operative day one ]

    Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.

  • Pain score [ Time Frame: One month postoperatively ]

    Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.

  • Pain score [ Time Frame: Three months postoperatively ]

    Pain score measured with a patient reported 11 point Numeric Rating Pain Scale with 0 indicating no pain and 10 indicating worst pain imaginable.

  • Opioid utilization [ Time Frame: Surgical completion to PACU discharge (usually one hour) ]

    Opioid utilization based on amount of opioid medications administered

  • Opioid utilization [ Time Frame: Postoperative day one ]

    Opioid utilization based on number of pain pills taken

  • Opioid utilization [ Time Frame: One month postoperatively ]

    Opioid utilization based on average number of pain pills taken per day

  • Opioid utilization [ Time Frame: Three months postoperatively ]

    Opioid utilization based on average number of pain pills taken per day

Secondary Outcome Measures:

Estimated Enrollment: 70
Anticipated Study Start Date: June 1, 2017
Estimated Study Completion Date: June 1, 2017
Estimated Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
Experimental: Subarachnoid block Procedure: Subarachnoid block

Neuraxial anesthesia will be performed at the L2-3 or L3-4 interspace with a 25-gauge Whitacre needle in the sitting position. After free flow of cerebrospinal fluid (CSF), 40-45mg of 2-chloroprocaine will be injected based on patient’s height and discretion of attending anesthesiologist, needle withdrawn and the patient placed supine.

Active Comparator: General anesthesia Procedure: General anesthesia

General anesthesia will be delivered per standard procedure. General anesthesia will include induction with propofol 1-3mg/kg followed by placement of a laryngeal mask airway with maintenance anesthesia of sevoflurane 0.5-1 minimum alveolar concentration (MAC).

The study evaluates the efficacy of two different anesthetic techniques in patients undergoing unilateral knee arthroscopy. Participants will be randomized to receive either subarachnoid block with 2-chloroprocaine or general anesthesia plus intravenous fentanyl. The study evaluates pain scores, opioid utilization and patient satisfaction.

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with ASA physical status classification of I, II, or III
  • Patients without a current diagnosis of chronic pain or chronic opioid use for > 1-month prior to knee arthroscopy
  • Patients who are scheduled to undergo unilateral knee arthroscopy
  • Patients do not have a contraindication to receiving regional anesthesia

Exclusion Criteria:

  • Preexisting sensory or motor deficit in operative extremity
  • Patients with a contraindication to general anesthesia
  • Patient undergoing meniscal or ligamentous repair

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03173326

Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Contact: Jenna Walters, M.D.         

Vanderbilt University Medical Center

Principal Investigator: Jenna Walters, M.D. Vanderbilt University Medical Center

Responsible Party: Jenna Walters, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03173326     History of Changes
Other Study ID Numbers: 170741
Study First Received: May 29, 2017
Last Updated: May 29, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anesthetics
Chloroprocaine
Procaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 01, 2017