A Phase 4 interventional study of bupivacaine 0.5% and Dexmedetomidine in Hysterectomy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
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
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.
Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
ASA classification I-ll,
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
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
patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) using Ultrasound-Guided TAP Block Technique
patients will receive plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side
patients will receive plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side
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)
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jan 2025; primary completion for Jan 2026, 12 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine