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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Perineural Dexamethasone and bupivacaine; Drug: Systemic Dexamethasone plus perineural bupivacaine; Drug: intravenous saline plus perineural bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: perineural dexamethasone group; 21 patients received perineural dexamethasone plus bupivacaine 0.5%	Drug: Perineural Dexamethasone and bupivacaine
Active Comparator: systemic dexamethasone group; 21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5%	Drug: Systemic Dexamethasone plus perineural bupivacaine
Sham Comparator: control group; 21 patients received only perineural bupivacaine 0.5% plus intravenous saline	Drug: intravenous saline plus perineural bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of onset of sensory blockade	from time of performing the nerve block till the occurrence of sensory block	upto 30 min
Time of onset of motor blockade	from time of performing the nerve block till the occurrence of motor block	up to 30 min
Duration of analgesia	time from onset of analgesia till the first request for an analgesic	upto 24 hours
Duration of motor blockade	time from motor blockade till ability to move the limb	upto 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative hemodynamics	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	time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval)

Collaborators and Investigators

• Sponsor: Sherif Mohamed Abd el moneim Soaida, MD

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: dexamethasone; bupivacaine; regional anesthesia; femoral; sciatic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Bupivacaine
• Other Study ID Numbers: SMS2015-1