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Completed

NCT Number: NCT01837394

Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

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.

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Key information

Conditions

Postoperative Pain Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Function Level Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Block of the SN and ONP

Procedure

7.5 ml of Ropivacaine 7.5 mg/ml injected at each site

Other names: Naropin

Placebo Block

Procedure

7.5 ml of isotonic saline solution 154 mmol/l injected at each site

Other names: NaCl

Paracetamol

Drug

Other names: Acetaminophen

Morphine

Drug

5 mg as needed

ondansetron

Drug

4 mg i.v. as needed in the PACU

Other names: Zofran

Metoclopramide

Drug

10 mg tablet as needed in the postoperative period after discharge from the PACU

Other names: Emperal, Primperan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jens Borglum Neimann

Other

Registry information

Official study title

Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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