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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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06720337
Enrollment
64
Registered
2024-12-06
Start date
2025-01-01
Completion date
2026-02-01
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

Keywords

ultrasound-Guided Transversus Abdominis Plane Block

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

Detailed description

In addition to parenteral opioids and NSAIDS, various other methods used for post operative analgesia are infiltration of local anaesthetic agents, dermal patches, patient-controlled analgesia and epidural catheters, etc. Numerous studies have demonstrated that when enhanced recovery procedures (ERPs) are used, hospital length of stay, time to return to normal function, postoperative ileus duration, thromboembolic complications, morbidity, and all of these factors are all reduced. In order to achieve the best pain treatment, many ERPs use a multimodal approach, decreasing the use of opioids as the primary analgesic in Favor of neuraxial and regional anaesthetic techniques. One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia.

Interventions

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

DRUGDexmedetomidine

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

DRUGMgSO4

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Patients will be randomly allocated into one of the two study designed groups using computer-generated random numbers table.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
the time of the first request of rescue analgesia24 hoursthe time of the first request of rescue analgesia (calculated from the time of the TAP block application)

Contacts

Primary ContactAbdelrahman Mahfouz Ali, resident doctor
AbdElrahman.15235516@med.aun.edu.eg+2 01023864487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026