Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

Sponsor

Jens Borglum Neimann (Other)

Overall Status

Completed

CT.gov ID

NCT01837394

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Postoperative Nausea and Vomiting Postoperative Function Level	Procedure: Block of the SN and ONP Procedure: Placebo block Drug: Paracetamol Drug: Morphine Drug: Ondansetron Drug: Metoclopramide	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Block of the SN and ONP 7.5 ml of Ropivacaine 7.5 mg/ml injected at each site Other Names: Naropin Drug: Paracetamol Other Names: Acetaminophen Drug: Morphine 5 mg as needed Drug: Ondansetron 4 mg i.v. as needed in the PACU Other Names: Zofran Drug: Metoclopramide 10 mg tablet as needed in the postoperative period after discharge from the PACU Other Names: Emperal Primperan
Placebo Comparator: 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.	Procedure: Placebo block 7.5 ml of isotonic saline solution 154 mmol/l injected at each site Other Names: NaCl Drug: Paracetamol Other Names: Acetaminophen Drug: Morphine 5 mg as needed Drug: Ondansetron 4 mg i.v. as needed in the PACU Other Names: Zofran Drug: Metoclopramide 10 mg tablet as needed in the postoperative period after discharge from the PACU Other Names: Emperal Primperan

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Block of the SN and ONP

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

Other Names:

Naropin

Drug: Paracetamol

Other Names:

Acetaminophen

Drug: Morphine

5 mg as needed

Drug: Ondansetron

4 mg i.v. as needed in the PACU

Other Names:

Zofran

Drug: Metoclopramide

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

Other Names:

Emperal

Primperan

Placebo Comparator: 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.

Procedure: Placebo block

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

Other Names:

NaCl

Drug: Paracetamol

Other Names:

Acetaminophen

Drug: Morphine

5 mg as needed

Drug: Ondansetron

4 mg i.v. as needed in the PACU

Other Names:

Zofran

Drug: Metoclopramide

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

Other Names:

Emperal

Primperan

Outcome Measures

Primary Outcome Measures

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

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
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.
Vomiting [24 hours]
Number of times the patient has vomited in the first 24 hours postoperatively.
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.
Function level: Barthel Index/100 [24 hours]
Modified Barthel Index/100 score 24 hours after the operation.
Function level: Short form (SF) -8 [24 hours]
Short form (SF) -8 questionnaire 24 hours postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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