Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

NCT01837394 | Completed Phase 4

• 1 other identifier: H-2-2011-029
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Postoperative Function Level

Keywords

Nerve block; Ultrasound; postoperative pain; Saphenous nerve; Obturator nerve

Outcome Measures

Primary Outcomes (1)

• Pain on knee flexion

  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.

  24 hours postoperatively

Secondary Outcomes (9)

• Pain at rest

  24 hours postoperatively

• Time to opioid intake

  24 hours postoperatively

• Total opioid intake

  24 hours

• Nausea

  24 hours postoperatively

• Vomiting

  24 hours

Study Arms (2)

Block arm

ACTIVE COMPARATOR

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; Drug: Paracetamol; Drug: Morphine; Drug: Ondansetron; Drug: Metoclopramide

Placebo arm

PLACEBO COMPARATOR

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; Drug: Paracetamol; Drug: Morphine; Drug: Ondansetron; Drug: Metoclopramide

Interventions

Block of the SN and ONP PROCEDURE

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

Also known as: Naropin

Block arm

Placebo block PROCEDURE

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

Also known as: NaCl

Placebo arm

Paracetamol DRUG

Also known as: Acetaminophen

Block arm; Placebo arm

Morphine DRUG

5 mg as needed

Block arm; Placebo arm

Ondansetron DRUG

4 mg i.v. as needed in the PACU

Also known as: Zofran

Block arm; Placebo arm

Metoclopramide DRUG

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

Also known as: Emperal, Primperan

Block arm; Placebo arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Borglum Neimann: lead

Study Sites (1)

Department of Anesthesiology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Ropivacaine; Acetaminophen; Morphine; Ondansetron; Metoclopramide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Bo Westergaard, MD

  Department of Anesthesiology, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, MBA

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 23, 2013
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

DK (1)