Ain Shams University
Cairo, Cairo Governorate, 1181, Egypt
NCT Number: NCT07418671
The current study was done to evaluate the effect of adding dexamethasone and magnesium sulfate to bupivacaine as adjuvants in an ultrasound-guided erector spinae block for patients undergoing total hip arthroplasty (THA), and to assess their impact on the timing of the first request for analgesia and on overall postoperative analgesic requirements.
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Notify Me22 year and older
All sexes
Interventional
Phase 2
Cairo, Cairo Governorate, 1181, Egypt
This study aimed to appraise the addition of dexamethasone and magnesium sulfate to bupivacaine as adjuvants by ultrasound-guided ESP block in patients having undergone total hip arthroplasty (THA) and its effect on the first analgesic request, total analgesic requirements.
This study was a prospective clinical study carried out to improve pain control after total hip arthroplasty (THA), which is a major orthopedic surgery often associated with significant postoperative discomfort. It is done to determine whether adding two commonly available medications-dexamethasone and magnesium sulfate-to the standard local anesthetic drug bupivacaine could enhance the effectiveness of the erector spinae plane (ESP) block.
The study included adult patients scheduled for elective total hip replacement surgery. All participants were carefully evaluated before enrollment to ensure they met specific inclusion criteria, such as appropriate age range, general health status, and absence of contraindications to regional anesthesia. Patients with conditions like known allergy to study drugs, severe coagulation problems, local infection at the injection site, or major systemic illness were excluded in order to maintain safety and reliability.
Participants were randomly divided into three groups. Each group received an ESP block under ultrasound guidance at the lumbar level at the end of surgery. Ultrasound was used to accurately identify the muscles, bones, and nerves of the lower back so that the anesthetic solution could be injected in the correct tissue plane. The groups are:
One group received bupivacaine plus saline (control group). A second group received bupivacaine with dexamethasone. A third group received bupivacaine with magnesium sulfate.
Following completion of the ESP block, patients were placed in a comfortable supine position and were subjected to continuous clinical observation to detect any procedure-related immediate complications. In the postoperative period, all study groups received the same standardized analgesic protocol and routine perioperative management to ensure uniformity of care and minimize bias. Assessment of pain severity was performed at predetermined regular intervals using validated scoring systems such as the Visual Analogue Scale. The precise duration of analgesia was determined by documenting the time to first postoperative analgesic request for each patient. Nursing staff recorded all additional analgesic medications administered during the first 24 hours after surgery, including total opioid consumption and rescue non-opioid analgesic requirements. Hemodynamic parameters, level of sedation, and possible adverse effects-such as postoperative nausea and vomiting, dizziness, local discomfort, hematoma formation, or signs of infection at the puncture site-were carefully monitored and documented. All collected clinical and laboratory data were subsequently coded and prepared for detailed statistical analysis in order to compare the efficacy of the different bupivacaine-adjuvant combinations in enhancing postoperative pain control after total hip arthroplasty.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bupivacaine plus Magnesium Sulphate (MgSO4) as adjuvant
Bupivacaine plus Dexamethasone as adjuvant
Bupivacaine plus Saline as control
Time frame: 24-HOURS
Post-operative analgesia duration, which is measured as the time to the first analgesic request by the patient
Time frame: 12 HOURS
the total dose of pethidine required by the patient within the first 12 hours after surgery
Time frame: 24-HOURS
Assessment of pain levels using the Visual Analogue Pain Scale every 2 hours for a total of 24 hours
Time frame: 24-HOURS
Monitoring for any adverse effects on heart rate
Time frame: 24-HOURS
Monitoring for any adverse effects on mean arterial blood pressure
Time frame: 24-HOURS
Monitoring for issues such as bleeding, hematoma, or local anesthetic toxicity over the first 24 hours
Ain Shams University
Other
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