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OpenTrials
Completed

NCT Number: NCT02576782

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineural Dexamethasone and bupivacaine

Drug

Systemic Dexamethasone plus perineural bupivacaine

Drug

intravenous saline plus perineural bupivacaine

Drug

Primary outcomes

  1. Time of onset of sensory blockade

    Time frame: upto 30 min

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

  2. Time of onset of motor blockade

    Time frame: up to 30 min

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

  3. Duration of analgesia

    Time frame: upto 24 hours

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

  4. Duration of motor blockade

    Time frame: upto 24 hours

    time from motor blockade till ability to move the limb

Secondary outcomes

  1. perioperative hemodynamics

    Time frame: time 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

Sponsors and collaborators

Lead sponsor

Sherif Mohamed Abd el moneim Soaida, MD

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2015
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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