An interventional study of Ropivacaine and placebo in Pain, Postoperative, sponsored by Jens Borglum Neimann. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-31.
Sponsored by Jens Borglum Neimann · Not applicable, Interventional, and Treatment
Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.
Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 82 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Jens Borglum Neimann is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Nerveblock of n. femoralis (FEM) with 10 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerveposterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml.
Drug: Ropivacaine
Nerveblock of n.saphenous (SAPH) with 5 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerve, posterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml
Drug: Ropivacaine
Saline 9 mg/ml
Drug: placebo
NRS (pain score)
Numerical rating scale(0-10)
Time frame: Area under the curve (AUC) 0-6 hours postoperatively
Opioid consumption
Opioid consumption (PCA pump - mg of morphine)
Time frame: 0-6 hours postoperatively
opioid related side effects
Nausea (0-3), vomiting (\>10 ml)
Time frame: 0-6 hours postoperatively
PACU time
Minutes in PACU
Time frame: 0-6 hours postoperatively
Motor abilities of of daily living
Modified Barthel/100 index
Time frame: 0-24 hours postoperatively
Perceived ill health
Short-Form-8
Time frame: 0-24 hours postoperatively
Degree of motor block.
Jensen-Borglum motor test
Time frame: 0-6 hours postoperatively
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Jens Borglum Neimann