Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837394
• Other study ID #: H-2-2011-029
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2013
• Last updated: November 5, 2013
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Function Level
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Procedure:
• Block of the SN and ONP
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
• Placebo block
7.5 ml of isotonic saline solution 154 mmol/l injected at each site

Drug:
• Paracetamol

• Morphine
5 mg as needed
• Ondansetron
4 mg i.v. as needed in the PACU
• Metoclopramide
10 mg tablet as needed in the postoperative period after discharge from the PACU

Locations

Country	Name	City	State
Denmark	Department of Anesthesiology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jens Borglum Neimann

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain at rest	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.	24 hours postoperatively	No
Secondary	Time to opioid intake	First time the patient needs to take supplementary opioids in the postoperative period	24 hours postoperatively	No
Secondary	Total opioid intake	Total dose of opioids taken in the first 24 hours postoperatively	24 hours	No
Secondary	Nausea	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.	24 hours postoperatively	No
Secondary	Vomiting	Number of times the patient has vomited in the first 24 hours postoperatively.	24 hours	No
Secondary	Use of antiemetics	Total dose of antiemetics taken during the first 24 hours postoperatively	24 hours	No
Secondary	PACU length of stay	Total length of stay in the post anesthetic care unit (PACU) after the operation.	24 hours	No
Secondary	Function level: Barthel Index/100	Modified Barthel Index/100 score 24 hours after the operation.	24 hours	No
Secondary	Function level: Short form (SF) -8	Short form (SF) -8 questionnaire 24 hours postoperatively	24 hours	No