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

NCT03173326 | Terminated

• 1 other identifier: 170741
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Arthroscopy; General Anesthesia; Subarachnoid Block

Outcome Measures

Primary Outcomes (8)

• Pain score

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

  Discharge from post anesthesia care unit (PACU) (usually one hour)

• Pain score

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

  Post operative day one

• Pain score

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

  One month postoperatively

• Pain score

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

  Three months postoperatively

• Opioid utilization

  Opioid utilization based on amount of opioid medications administered

  Surgical completion to PACU discharge (usually one hour)

• Opioid utilization

  Opioid utilization based on number of pain pills taken

  Postoperative day one

• Opioid utilization

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

  One month postoperatively

• Opioid utilization

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

  Three months postoperatively

Secondary Outcomes (1)

• Patient satisfaction with anesthetic

  24 hours after PACU discharge

Study Arms (2)

Subarachnoid block

EXPERIMENTAL

Procedure: Subarachnoid block

General anesthesia

ACTIVE COMPARATOR

Procedure: General anesthesia

Interventions

General anesthesia PROCEDURE

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).

General anesthesia

Subarachnoid block PROCEDURE

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.

Subarachnoid block

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Interventions

Anesthesia, General; Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anesthesia, Conduction

Study Officials

• Jenna Walters, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 1, 2017
• Study Start: June 16, 2017
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)