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Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Function Level

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Block of the SN and ONP
Placebo block
Paracetamol
Morphine
Ondansetron
Metoclopramide
Sponsored by
Jens Borglum Neimann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Nerve block, Ultrasound, postoperative pain, Saphenous nerve, Obturator nerve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Block arm

Placebo arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2013
Last Updated
November 5, 2013
Sponsor
Jens Borglum Neimann
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1. Study Identification

Unique Protocol Identification Number
NCT01837394
Brief Title
Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy
Official Title
Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Borglum Neimann

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea and Vomiting, Postoperative Function Level
Keywords
Nerve block, Ultrasound, postoperative pain, Saphenous nerve, Obturator nerve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Block arm
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Block of the SN and ONP
Other Intervention Name(s)
Naropin
Intervention Description
7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
Intervention Type
Procedure
Intervention Name(s)
Placebo block
Other Intervention Name(s)
NaCl
Intervention Description
7.5 ml of isotonic saline solution 154 mmol/l injected at each site
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
5 mg as needed
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
4 mg i.v. as needed in the PACU
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Emperal, Primperan
Intervention Description
10 mg tablet as needed in the postoperative period after discharge from the PACU
Primary Outcome Measure Information:
Title
Pain on knee flexion
Description
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.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain at rest
Description
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 Frame
24 hours postoperatively
Title
Time to opioid intake
Description
First time the patient needs to take supplementary opioids in the postoperative period
Time Frame
24 hours postoperatively
Title
Total opioid intake
Description
Total dose of opioids taken in the first 24 hours postoperatively
Time Frame
24 hours
Title
Nausea
Description
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.
Time Frame
24 hours postoperatively
Title
Vomiting
Description
Number of times the patient has vomited in the first 24 hours postoperatively.
Time Frame
24 hours
Title
Use of antiemetics
Description
Total dose of antiemetics taken during the first 24 hours postoperatively
Time Frame
24 hours
Title
PACU length of stay
Description
Total length of stay in the post anesthetic care unit (PACU) after the operation.
Time Frame
24 hours
Title
Function level: Barthel Index/100
Description
Modified Barthel Index/100 score 24 hours after the operation.
Time Frame
24 hours
Title
Function level: Short form (SF) -8
Description
Short form (SF) -8 questionnaire 24 hours postoperatively
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Westergaard, MD
Organizational Affiliation
Department of Anesthesiology, Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

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Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

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