Comparative Study Between the Analgesic Effect of Dexmedetomidine and Magnesium Sulfate As Adjuvant to Bupivacaine Using Ultrasound-Guided Transversus Abdominis Plane Block in Abdominal Hysterectomy : a Randomized Double-blinded Study

NCT06720337 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Dexmedetomidine and Mgso4 TAP
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Over 80% of patients who undergo surgery suffer from acute postoperative pain, with 75% of them rating the pain severity as moderate, severe, or extreme. Studies have shown that less than 50% of patients who undergo surgery report adequate relief from postoperative pain. Additionally, if pain is not promptly managed after surgery, it can hinder a patient's ability to walk, potentially causing adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia. The opioid analgesics are most commonly used as parenteral agents to manage post operative pain but the problem of respiratory depression remains to be considered. This study is designed to compare the analgesic effect between dexmedetomidine versus magnesium sulfate as adjuvant to bupivacaine using ultrasound guided Transversus Abdominis Plane block in patients undergoing abdominal hysterectomy

Conditions

Hysterectomy

Keywords

ultrasound-Guided Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

• the time of the first request of rescue analgesia

  the time of the first request of rescue analgesia (calculated from the time of the TAP block application)

  24 hours

Study Arms (2)

group A

EXPERIMENTAL

Patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side

Drug: bupivacaine 0.5%; Drug: Dexmedetomidine

group b

EXPERIMENTAL

patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side

Drug: bupivacaine 0.5%; Drug: MgSO4

Interventions

bupivacaine 0.5% DRUG

patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) using Ultrasound-Guided TAP Block Technique

group A; group b

Dexmedetomidine DRUG

patients will receive plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side

group A

MgSO4 DRUG

patients will receive plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side

group b

Eligibility Criteria

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

You may qualify if:

• ASA classification I-ll,
• Aged \>18 years,
• weight 50-85 kg,
• Patients who will undergo total abdominal hysterectomy

You may not qualify if:

• ASA classification I-ll,
• Aged \>18 years,
• weight 50-85 kg,
• Patients who will undergo total abdominal hysterectomy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.

  PMID: 25580086 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Abdelrahman Mahfouz Ali, resident doctor

CONTACT

+2 01023864487; AbdElrahman.15235516@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly allocated into one of the two study designed groups using computer-generated random numbers table.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anaesthesia, Intensive Care and Pain Management department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share