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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

NCT06864416

Post Operative Pain

COMPLETED PHASE4

Effect of Dexamethasone and Epinephrine on the Duration of Sciatic Nerve Blocks With Ropivacaine

NCT02104778

Postoperative Pain

UNKNOWN NA

Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity

NCT07276867

Intrathecal Dexmedetomidine Fentanyl +5 more

RECRUITING NA

Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg

NCT01641419

Pain, Sciatic Block

WITHDRAWN NA

Dexmedetomidine Combined With Bupivacaine in Ultrasound-guided Pecto-Intercostal Fascial Block in Cardiac Surgery

NCT07023874

Postoperative Pain Cardiac Surgery

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

perineural dexamethasone group

21 patients received perineural dexamethasone plus bupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Perineural Dexamethasone and bupivacaine

Intervention Type DRUG

systemic dexamethasone group

21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Systemic Dexamethasone plus perineural bupivacaine

Intervention Type DRUG

control group

21 patients received only perineural bupivacaine 0.5% plus intravenous saline

Group Type SHAM_COMPARATOR

intravenous saline plus perineural bupivacaine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Perineural Dexamethasone and bupivacaine

Intervention Type DRUG

Systemic Dexamethasone plus perineural bupivacaine

Intervention Type DRUG

intravenous saline plus perineural bupivacaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No