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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Notify MeKey information
Conditions
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
Systemic Dexamethasone plus perineural bupivacaine
Drugintravenous saline plus perineural bupivacaine
DrugPrimary outcomes
-
Time of onset of sensory blockade
Time frame: upto 30 min
from time of performing the nerve block till the occurrence of sensory block
-
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
-
Duration of analgesia
Time frame: upto 24 hours
time from onset of analgesia till the first request for an analgesic
-
Duration of motor blockade
Time frame: upto 24 hours
time from motor blockade till ability to move the limb
Secondary outcomes
-
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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