Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction
Phase 3
Completed
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT02749162
- Lead Sponsor
- Foisor Orthopedics Clinical Hospital
- Brief Summary
The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration of analgesia continues to be under debate. The investigators performed a prospective randomized study to evaluate the effect of perineural dexamethasone in different concentrations in postoperative analgesia in femoral nerve block for anterior cruciate ligament reconstruction.
- Detailed Description
After Ethics committee approval, 75 patients American Society of Anesthesiologists score (ASA) I-III were randomized at the end of surgery into 3 groups of 25 patients each who underwent femoral nerve block: group A with 20 ml ropivacaine 0,5% and 20 ml lidocaine 1%; group B with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 4 mg dexamethasone; group C with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 8 mg dexamethasone.
All groups received postoperative analgesia when visual analog scale (VAS) over 3 (by request), with IV Perfalgan 1 g and morphine (loading dose 0.1 mg/kg and titration until VAS under 3, followed by subcutaneous (SC) administration of 1/2 of total loading dose on demand for the following 24 hours (h) .
Efficacy was evaluated by the time interval from performing the block until the first analgesic dose required, the total amount of morphine in the first 24 h postoperative, the patient satisfaction and the neurological side effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- ASA I-III
- BMI<40
Exclusion Criteria
- High risk grade hypertension
- Chronic renal failure
- Known allergy to drugs used
- Chronic treatment with steroids
- Drugs dependency
- History of diabetes mellitus
- Ulcer or chronic gastritis
- Infection on the puncture site
- Neuropathy at the surgical level
- Coagulopathy
- Requesting another type of anesthesia
- Fear to sign informed consent
- By-pass aorto-femoral
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Paracetamol After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group C Ropivacaine After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group A Paracetamol After the spinal anesthesia regressed, the investigators performed a single shot femoral block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group A Morphine After the spinal anesthesia regressed, the investigators performed a single shot femoral block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group A Ropivacaine After the spinal anesthesia regressed, the investigators performed a single shot femoral block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group A Lidocaine After the spinal anesthesia regressed, the investigators performed a single shot femoral block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group B Dexamethasone phosphate After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group B Morphine After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group C Dexamethasone phosphate After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group B Lidocaine After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group B Ropivacaine After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group C Paracetamol After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group C Morphine After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request. Group C Lidocaine After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS \<3. After 2 h morphine was administered SC ½ of the total loading dose at request.
- Primary Outcome Measures
Name Time Method the total amount of morphine At 24 hour postoperative the morphine administered in milligrams
- Secondary Outcome Measures
Name Time Method duration of analgesia the first 24 hours the time interval from performing the block until the first analgesic dose required at VAS \>3 (0 - no pain, 10 - the worst pain possible
the number of patients with neurological sensibility side effects At 21 days postoperative Following postoperative sensibility of operated lower limb by pinprick test
the patient satisfaction At 24 hour postoperative evaluation of satisfaction by a questionnaire
the number of patients with neurological motility side effects At 24 h postoperative Following the postoperative motility of operated lower limb by Bromage scale
Trial Locations
- Locations (1)
Foisor Orthopedics Clinical Hospital
🇷🇴Bucharest, Romania