Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy
Overview
- Phase
- Phase 4
- Intervention
- Block of the SN and ONP
- Conditions
- Postoperative Pain
- Sponsor
- Jens Borglum Neimann
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain on knee flexion
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Jens Borglum Neimann
MD, PhD, MBA
Bispebjerg Hospital
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
Arms & Interventions
Block arm
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.
Intervention: Block of the SN and ONP
Block arm
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.
Intervention: Paracetamol
Block arm
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.
Intervention: Morphine
Block arm
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.
Intervention: Ondansetron
Block arm
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.
Intervention: Metoclopramide
Placebo arm
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: Placebo block
Placebo arm
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: Paracetamol
Placebo arm
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: Morphine
Placebo arm
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: Ondansetron
Placebo arm
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: Metoclopramide
Outcomes
Primary Outcomes
Pain on knee flexion
Time Frame: 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 Outcomes
- Use of antiemetics(24 hours)
- PACU length of stay(24 hours)
- Nausea(24 hours postoperatively)
- Function level: Short form (SF) -8(24 hours)
- Pain at rest(24 hours postoperatively)
- Time to opioid intake(24 hours postoperatively)
- Total opioid intake(24 hours)
- Vomiting(24 hours)
- Function level: Barthel Index/100(24 hours)