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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576782
• Other study ID #: SMS2015-1
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2015
• Last updated: October 13, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Cairo university
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Perineural Dexamethasone and bupivacaine

• Systemic Dexamethasone plus perineural bupivacaine

• intravenous saline plus perineural bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sherif Mohamed Abd el moneim Soaida, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of onset of sensory blockade	from time of performing the nerve block till the occurrence of sensory block	upto 30 min	No
Primary	Time of onset of motor blockade	from time of performing the nerve block till the occurrence of motor block	up to 30 min	No
Primary	Duration of analgesia	time from onset of analgesia till the first request for an analgesic	upto 24 hours	No
Primary	Duration of motor blockade	time from motor blockade till ability to move the limb	upto 24 hours	No
Secondary	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)	No