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Dexamethasone & Bupivacaine vs Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Perioperative Analgesia in Patients Undergoing Lower Limb Surgeries

Phase 4
Completed
Conditions
Pain
Interventions
Registration Number
NCT02576782
Lead Sponsor
Sherif Mohamed Abd el moneim Soaida, MD
Brief Summary

In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks.

Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications.

The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of:

* Onset of sensory blockade and motor blockade

* Duration of analgesia / first request for analgesic

* Duration of motor blockade

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
Inclusion Criteria
  • Age ranging from 18 to 70 years
  • American Society of Anesthesiologists (ASA) physical status I, II and III
  • Patients scheduled for lower limb vascular surgeries
Exclusion Criteria
  • Patient refusal for the procedure
  • Any bleeding disorder or patients on anticoagulant therapy
  • Neurological deficits involving lumbar or sacral plexuses
  • Patients with allergy to local anaesthetics
  • Local infection at the injection site
  • Patients on any sedative or antipsychotic drugs
  • Body mass index > 35

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
perineural dexamethasone groupPerineural Dexamethasone and bupivacaine21 patients received perineural dexamethasone plus bupivacaine 0.5%
systemic dexamethasone groupSystemic Dexamethasone plus perineural bupivacaine21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5%
control groupintravenous saline plus perineural bupivacaine21 patients received only perineural bupivacaine 0.5% plus intravenous saline
Primary Outcome Measures
NameTimeMethod
Time of onset of motor blockadeup to 30 min

from time of performing the nerve block till the occurrence of motor block

Duration of analgesiaupto 24 hours

time from onset of analgesia till the first request for an analgesic

Duration of motor blockadeupto 24 hours

time from motor blockade till ability to move the limb

Time of onset of sensory blockadeupto 30 min

from time of performing the nerve block till the occurrence of sensory block

Secondary Outcome Measures
NameTimeMethod
perioperative hemodynamicstime immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval)

systolic and diastolic blood pressure, heart rate before starting the procedure;Respiratory rate;and Oxygen saturation during the procedure and in the 24 hours following the procedure

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