A Phase 4 interventional study of Bupivacaine and Magnesium Sulfate and Bupivacaine 0.125% in Upper Abdominal Cancer Surgery, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Assiut University · Phase 4, Interventional, and Treatment
double blind randomized controlled trial will be conducted on upper abdominal cancer surgery cases to study the effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery
Despite advances in the field of medical and radiation oncology, surgical resection is a crucial intervention and remains the mainstay of gold standard treatment. Upper abdominal incisions such as the oblique subcostal laparotomy are a cause of severe pain and can lead to significant respiratory impairment . 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. Traditionally, epidural analgesia has been the cornerstone of pain control in such surgeries. However, it has limitations, including potential complications and contraindications in certain patients.
The innervation of the upper abdominal wall originates from the T6th and T10th intercostal nerves and requires effective blocking of these nerves to achieve analgesic and anesthetic efficacy. For upper abdominal surgeries, the ideal regional anesthesia technique should target both the anterior and lateral cutaneous branches of the intercostal nerves from T6 to T10. Hesham Elsharkawy et al demonstrated the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia. The external oblique intercostal (EOI) block has shown promising results in covering the anterior and lateral upper abdominal wall. It's simple, effective, and convenient block, particularly in the context of morbid obesity.
The external oblique intercostal block offers effective pain relief for the upper abdomen without the systemic effects of sympathetic blockade and without impairing motor or bladder function. It ensure optimal pain management, promote early postoperative mobilization, and support functional recovery.
Magnesium is a calcium blocker and an NMDA receptor antagonist. Research has demonstrated that magnesium sulfate [MgSO4] has an analgesic effect by blocking N-methyl-D-aspartate [NMDA] receptors and associated calcium channels, thereby preventing central sensitization that arises due to peripheral nociceptive stimulation. Magnesium may influence the central nervous system's (CNS) ability to transmit nociceptive signals and pain sensation in the central nervous system (CNS) by inhibiting N-methyl-D-aspartate (NMDA) receptor and calcium channels. It was used recently as a powerful analgesic adjuvant resulting in reduced postoperative opioid consumption.
67 studies on the registry are indexed under Abdominal Neoplasms; 18 are open to participants now.
This study's planned enrollment of 68 is close to the median of 74 across 49 interventional studies indexed under Abdominal Neoplasms.
Browse Abdominal Neoplasms studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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Exclusion Criteria:
Drug: Bupivacaine
Drug: Magnesium Sulfate and Bupivacaine 0.125%
External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25% only bilateral
External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25%+200 mg magnesium sulphate bilateral
dose postoperative opioid consumption
the total dose postoperative opioid consumption in the first 24 h.
Time frame: baseline
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
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Assiut University