Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting; Postoperative Function Level; Postoperative Pain
• Interventions: Procedure: Block of the SN and ONP; Procedure: Placebo block; Drug: Paracetamol; Drug: Morphine; Drug: Ondansetron; Drug: Metoclopramide

• Registration Number: NCT01837394
• Lead Sponsor: Jens Borglum Neimann

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block arm	Block of the SN and ONP	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.
Placebo arm	Placebo block	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.
Block arm	Paracetamol	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.
Block arm	Morphine	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.
Block arm	Ondansetron	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.
Block arm	Metoclopramide	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.
Placebo arm	Morphine	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.
Placebo arm	Ondansetron	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.
Placebo arm	Paracetamol	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.
Placebo arm	Metoclopramide	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.

Primary Outcome Measures

Name	Time	Method
Pain on knee flexion	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

Name	Time	Method
Use of antiemetics	24 hours	Total dose of antiemetics taken during the first 24 hours postoperatively
PACU length of stay	24 hours	Total length of stay in the post anesthetic care unit (PACU) after the operation.
Nausea	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.
Function level: Short form (SF) -8	24 hours	Short form (SF) -8 questionnaire 24 hours postoperatively
Pain at rest	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.
Time to opioid intake	24 hours postoperatively	First time the patient needs to take supplementary opioids in the postoperative period
Total opioid intake	24 hours	Total dose of opioids taken in the first 24 hours postoperatively
Vomiting	24 hours	Number of times the patient has vomited in the first 24 hours postoperatively.
Function level: Barthel Index/100	24 hours	Modified Barthel Index/100 score 24 hours after the operation.

Trial Locations

Locations (1)

Department of Anesthesiology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark