Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01837394
First received: April 15, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

In this study, we wish to investigate the effect of ultrasound (US) -guided block of the saphenous nerve (SN) and the posterior branch of the obturator nerve (ONP) on postoperative pain and the use of opioids (morphine-like pain medicine) in the first 24 hours following ambulatory knee arthroscopy.

We wish to investigate the analgesic effect of these two blocks compared to placebo (injection of local anesthetic with known pain blocking properties compared with injection of a saline solution), when used as a supplement to conventional oral analgesics.

We hypothesize that patients receiving the active treatment may experience less pain during the first 24 hours after their operation than patients receiving the placebo treatment, and possibly require less opioid analgesics, experience less opioid related side effects and have a higher function level in this period than patients receiving the placebo treatment.


Condition Intervention Phase
Postoperative Pain
Postoperative Nausea and Vomiting
Postoperative Function Level
Procedure: Block of the SN and ONP
Procedure: Placebo block
Drug: Paracetamol
Drug: Morphine
Drug: Ondansetron
Drug: Metoclopramide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Pain on knee flexion [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    VRS (Verbal Rating Scale) score 0-10 on active flexion of the knee to 45 degrees, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.


Secondary Outcome Measures:
  • Pain at rest [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    VRS (verbal rating score) 0-10 at rest, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.

  • Time to opioid intake [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    First time the patient needs to take supplementary opioids in the postoperative period

  • Total opioid intake [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total dose of opioids taken in the first 24 hours postoperatively

  • Nausea [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    VRS score 0-10, measured at 0, ½, 1, 2, 3, 4, 6, 8, 12 and 24 hours postoperatively and analyzed by area under curve (AUC) analysis.

  • Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Number of times the patient has vomited in the first 24 hours postoperatively.

  • Use of antiemetics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total dose of antiemetics taken during the first 24 hours postoperatively

  • PACU length of stay [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total length of stay in the post anesthetic care unit (PACU) after the operation.

  • Function level: Barthel Index/100 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Modified Barthel Index/100 score 24 hours after the operation.

  • Function level: Short form (SF) -8 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Short form (SF) -8 questionnaire 24 hours postoperatively


Enrollment: 60
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Block arm
Ultrasound guided block of the SN and ONP with 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
Procedure: Block of the SN and ONP
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
Other Name: Naropin
Drug: Paracetamol
Other Name: Acetaminophen
Drug: Morphine
5 mg as needed
Drug: Ondansetron
4 mg i.v. as needed in the PACU
Other Name: Zofran
Drug: Metoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU
Other Names:
  • Emperal
  • Primperan
Placebo Comparator: Placebo arm
Ultrasound guided placebo block of the SN and ONP with 7.5 ml of isotonic saline solution injected at each site, respectively, immediately prior to induction of general anesthesia. Standard postoperative analgesia with paracetamol 1 g every 6 hours and Morphine 5 mg as needed. Ondansetron or Metoclopramide as needed for nausea.
Procedure: Placebo block
7.5 ml of isotonic saline solution 154 mmol/l injected at each site
Other Name: NaCl
Drug: Paracetamol
Other Name: Acetaminophen
Drug: Morphine
5 mg as needed
Drug: Ondansetron
4 mg i.v. as needed in the PACU
Other Name: Zofran
Drug: Metoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU
Other Names:
  • Emperal
  • Primperan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned ambulatory knee arthroscopy, except cruciate ligament surgery
  • American Society of Anesthesiologists (ASA) class 1-3

Exclusion Criteria:

  • Cannot cooperate
  • Do not speak or understand Danish
  • Daily use of opioid analgesics
  • Allergy towards any of the drugs used in the investigation
  • Medicine abuse (at the investigators discretion)
  • Alcohol abuse, as defined by the National Board of Health
  • General anesthesia contraindicated, or the patient wants spinal anesthesia
  • Visualization of necessary structures by ultrasound not possible, or block not possible for other technical reasons
  Contacts and Locations
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: NCT01837394

Locations
Denmark
Department of Anesthesiology, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Jens Borglum Neimann
Investigators
Principal Investigator: Bo Westergaard, MD Department of Anesthesiology, Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Jens Borglum Neimann, MD, PhD, MBA, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01837394     History of Changes
Other Study ID Numbers: H-2-2011-029
Study First Received: April 15, 2013
Last Updated: November 5, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:
Nerve block
Ultrasound
postoperative pain
Saphenous nerve
Obturator nerve

Additional relevant MeSH terms:
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Nausea
Acetaminophen
Morphine
Metoclopramide
Ondansetron
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 24, 2014