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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

Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02576782
Enrollment
63
Registered
2015-10-15
Start date
2013-06-30
Completion date
2015-01-31
Last updated
2015-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

regional anesthesia, dexamethasone, bupivacaine, femoral, sciatic

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

Interventions

DRUGPerineural Dexamethasone and bupivacaine
DRUGSystemic Dexamethasone plus perineural bupivacaine
DRUGintravenous saline plus perineural bupivacaine

Sponsors

Sherif Mohamed Abd el moneim Soaida, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time of onset of sensory blockadeupto 30 minfrom time of performing the nerve block till the occurrence of sensory block
Time of onset of motor blockadeup to 30 minfrom time of performing the nerve block till the occurrence of motor block
Duration of analgesiaupto 24 hourstime from onset of analgesia till the first request for an analgesic
Duration of motor blockadeupto 24 hourstime from motor blockade till ability to move the limb

Secondary

MeasureTime frameDescription
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026