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Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

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ClinicalTrials.gov Identifier: NCT01837394
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital

Brief Summary:

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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Pain on knee flexion [ Time Frame: 24 hours postoperatively ]
    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 :
  1. Pain at rest [ Time Frame: 24 hours postoperatively ]
    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.

  2. Time to opioid intake [ Time Frame: 24 hours postoperatively ]
    First time the patient needs to take supplementary opioids in the postoperative period

  3. Total opioid intake [ Time Frame: 24 hours ]
    Total dose of opioids taken in the first 24 hours postoperatively

  4. Nausea [ Time Frame: 24 hours postoperatively ]
    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.

  5. Vomiting [ Time Frame: 24 hours ]
    Number of times the patient has vomited in the first 24 hours postoperatively.

  6. Use of antiemetics [ Time Frame: 24 hours ]
    Total dose of antiemetics taken during the first 24 hours postoperatively

  7. PACU length of stay [ Time Frame: 24 hours ]
    Total length of stay in the post anesthetic care unit (PACU) after the operation.

  8. Function level: Barthel Index/100 [ Time Frame: 24 hours ]
    Modified Barthel Index/100 score 24 hours after the operation.

  9. Function level: Short form (SF) -8 [ Time Frame: 24 hours ]
    Short form (SF) -8 questionnaire 24 hours postoperatively



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Jens Borglum Neimann, Bispebjerg Hospital:
Nerve block
Ultrasound
postoperative pain
Saphenous nerve
Obturator nerve

Additional relevant MeSH terms:
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Nausea
Morphine
Acetaminophen
Ondansetron
Metoclopramide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists