Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

Postoperative Pain Clinical Trial

Official title:

Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749162
• Other study ID #: ID AN-001-14
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2016
• Last updated: August 1, 2017
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Foisor Orthopedics Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone phosphate
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
• Paracetamol
After the block regression, at the first analgetic request the patients received the analgesia protocol
• Morphine
After the block regression, at the first analgetic request the patients received the analgesia protocol
• Lidocaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
• Ropivacaine
At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation

Locations

Country	Name	City	State
Romania	Foisor Orthopedics Clinical Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Foisor Orthopedics Clinical Hospital

Country where clinical trial is conducted

Romania, 

References & Publications (5)

Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49. Review. — View Citation

De Oliveira GS Jr, Castro Alves LJ, Nader A, Kendall MC, Rahangdale R, McCarthy RJ. Perineural dexamethasone to improve postoperative analgesia with peripheral nerve blocks: a meta-analysis of randomized controlled trials. Pain Res Treat. 2014;2014:179029 — View Citation

Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248. Review. — View Citation

Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70. — View Citation

Williams BA, Schott NJ, Mangione MP, Ibinson JW. Perineural dexamethasone and multimodal perineural analgesia: how much is too much? Anesth Analg. 2014 May;118(5):912-4. doi: 10.1213/ANE.0000000000000203. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the total amount of morphine	the morphine administered in milligrams	At 24 hour postoperative
Secondary	the patient satisfaction	evaluation of satisfaction by a questionnaire	At 24 hour postoperative
Secondary	the number of patients with neurological motility side effects	Following the postoperative motility of operated lower limb by Bromage scale	At 24 h postoperative
Secondary	duration of analgesia	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 first 24 hours
Secondary	the number of patients with neurological sensibility side effects	Following postoperative sensibility of operated lower limb by pinprick test	At 21 days postoperative