Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

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

Sponsors

Lead Sponsor: Jens Borglum Neimann

Source 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.

Overall Status Completed
Start Date August 2012
Completion Date September 2013
Primary Completion Date June 2013
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain on knee flexion 24 hours postoperatively
Secondary Outcome
Measure Time Frame
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
Use of antiemetics 24 hours
PACU length of stay 24 hours
Function level: Barthel Index/100 24 hours
Function level: Short form (SF) -8 24 hours
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Block of the SN and ONP

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

Arm Group Label: Block arm

Other Name: Naropin

Intervention Type: Procedure

Intervention Name: Placebo block

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

Arm Group Label: Placebo arm

Other Name: NaCl

Intervention Type: Drug

Intervention Name: Paracetamol

Other Name: Acetaminophen

Intervention Type: Drug

Intervention Name: Morphine

Description: 5 mg as needed

Intervention Type: Drug

Intervention Name: Ondansetron

Description: 4 mg i.v. as needed in the PACU

Other Name: Zofran

Intervention Type: Drug

Intervention Name: Metoclopramide

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

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bo Westergaard, MD Principal Investigator Department of Anesthesiology, Bispebjerg Hospital
Location
Facility: Department of Anesthesiology, Bispebjerg Hospital
Location Countries

Denmark

Verification Date

November 2013

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Bispebjerg Hospital

Investigator Full Name: Jens Borglum Neimann

Investigator Title: MD, PhD, MBA

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Block arm

Type: Active Comparator

Description: 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.

Label: Placebo arm

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov