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

NCT02576782 | Completed Phase 4

• 1 other identifier: SMS2015-1
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pain

Keywords

regional anesthesia; dexamethasone; bupivacaine; femoral; sciatic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• perioperative hemodynamics

  time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval)

Study Arms (3)

perineural dexamethasone group

ACTIVE COMPARATOR

21 patients received perineural dexamethasone plus bupivacaine 0.5%

Drug: Perineural Dexamethasone and bupivacaine

systemic dexamethasone group

ACTIVE COMPARATOR

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

Drug: Systemic Dexamethasone plus perineural bupivacaine

control group

SHAM COMPARATOR

21 patients received only perineural bupivacaine 0.5% plus intravenous saline

Drug: intravenous saline plus perineural bupivacaine

Interventions

Perineural Dexamethasone and bupivacaine DRUG

perineural dexamethasone group

Systemic Dexamethasone plus perineural bupivacaine DRUG

systemic dexamethasone group

intravenous saline plus perineural bupivacaine DRUG

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sherif Mohamed Abd el moneim Soaida, MD: lead

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 15, 2015
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: October 15, 2015

Record last verified: 2015-10