Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05578885
Other study ID # IVRA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date July 1, 2024

Study information

Verified date January 2024
Source Assiut University
Contact Michael Shehata, Resident
Phone +201022609690
Email michaelbeshay260@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intravenous regional anesthesia (Bier block) is widely used as an anesthetic technique for operations of short duration of the distal upper or lower extremities Today, IVRA is still popular in many countries being used in the emergency room, for outpatients and for high-risk patients with contraindications for general anesthesia.


Description:

IVRA offers a favorable risk-benefit ratio, cost-effectiveness, sufficient muscle relaxation and a fast on- and offset. New upcoming methods for monitoring, specialized personnel and improved emergency equipment made IVRA even safer. Moreover, IVRA may be applied to treat complex regional pain syndromes. Prilocaine and lidocaine are considered as first-choice local anesthetics for IVRA. Also, various adjuvant drugs have been tested to augment the effect of IVRA, and to reduce post-deflation tourniquet pain. Since major adverse events are rare in IVRA, it is regarded as a very safe technique. Nevertheless, systemic neuro- and cardiotoxic side effects may be linked to an uncontrolled systemic flush-in of local anesthetics and must be avoided. Dexamethasone decreases postoperative pain and prolongs the duration of local anaesthetic peripheral nerve blocks in studies including a limited number of patients . Fentanyl is a powerful synthetic opioid that is similar to morphine but is 50 to 100 times more potent.fentanyl acts on opioid receptors. These receptors are G-protein-coupled receptors, which contain seven transmembrane portions, intracellular loops, extracellular loops, intracellular C-terminus, and extracellular N-terminus. The extracellular N-terminus is important in differentiating different types of binding substrates. When fentanyl binds, downstream signaling leads to the inhibitory effects, such as decreased cAMP production, decreased calcium ion influx, and increased potassium efflux. This inhibits the ascending pathways in the central nervous system to increase pain threshold by changing the perception of pain; this is mediated by decreasing propagation of nociceptive signals, resulting in analgesic effects


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - ASA Grade 1 & 2 Exclusion Criteria: Patient refusal ASA Grade 3 & 4 patients SEVERLY HYPOVOLEMIC STATE History of neurological. Reynauds disease, scleroderma, sickle cell anemia, myasthenia gravis, decompensated cardiac disease, diabetes mellitus, peptic ulcer, gastritis, and those with liver or renal insufficiency were excluded

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bier block
patients in group a (n = 25) received 2% lidocaine3 mg/kg (maximum, 200 mg) for IVRA and 2 mL NaCl 0.9% IV , patients in group b (n = 25) received 2% lidocaine 3 mg/kg (maximum, 200 mg) plus 8 mg dexamethasone for IVRA and 2 mL NaCl 0.9% IV , and those in group c (n = 25) received 2% lidocaine 3 mg/kg (maximum, 200 mg) plus fentanyl IV

Locations

Country Name City State
Egypt Faculty of medicine Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Michael Bishay Shehata Keroles

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare duration of analgesia Change in the time of analgesia one hour After procedure
See also
  Status Clinical Trial Phase
Recruiting NCT05944393 - Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery N/A
Recruiting NCT05589246 - Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure N/A
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Terminated NCT02846610 - Registry for Acute Pain Treatment
Completed NCT03679897 - Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block Phase 4
Recruiting NCT06014749 - Serratus Intercostal Block Versus Epidural Analgesia in Eventration: Prospective Observational Study
Completed NCT04438369 - Evaluation of Ultrasound-guided Erector Spinae Block for Postoperative Analgesia in Laprascopic Ventral Hernia Repair. N/A
Terminated NCT03500744 - Erector Spinae Plane Block for Major Gynecologic and Urologic Surgery N/A
Completed NCT05160298 - Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery Phase 2
Recruiting NCT06121726 - Predictive Factors for the Effectiveness of the Ilioinguinal Iliohypogastric Nerve Block for Hernia Surgery
Completed NCT04549090 - Ultrasound Guided Posterior Quadratus Lumborum Block for Postoperative Analgesia in Gynecologic Surgery
Completed NCT05286190 - Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair N/A
Completed NCT02200016 - Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery Phase 4
Recruiting NCT06089798 - Analgesic Efficacy of Ultrasound-guided Bilateral Pecto-intercostal Plane Block in Pediatric Cardiac Surgery
Not yet recruiting NCT06115720 - Consent in Anaesthesia N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT05344105 - Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block N/A
Not yet recruiting NCT06313294 - Postoperative Follow-up Via Text Messages Automated Versus Telephone in Patients With Continuous Regional Anesthesia N/A
Completed NCT02950558 - Anesthesia for Pain After Ankle Fracture Surgery Phase 4
Completed NCT05351151 - Pain Reduction in Maxillomandibular Surgery Using Maxillary and Mandibular Nerve Blocks N/A