A Phase 3 interventional study of Block group and Morphine infusion in Perioperative Analgesia in Major Upper Abdominal Surgery, sponsored by Alexandria University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Alexandria University · Phase 3, Interventional, and Treatment
Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.
Regional blocks allow better pain control and avoid side effects of opioid based pain control
Ultrasound guided External oblique intercostal plane block for perioperative analgesia in major upper abdominal surgery: Prospective randomized controlled study
Introduction:
Pain control is a vital component to achieve enhanced recovery after major upper abdominal surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.
Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Epidural analgesia, another routinely used analgesic technique, offers equivalent or superior pain scores when compared to conventional systemic opioids. Enhanced recovery following major upper abdominal surgery has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.
The external oblique intercostal plane block is a new modality that will be used to improve pain-related outcomes after major upper abdominal surgeries, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane block can reduce cumulative opioid consumption for the patients undergoing major upper abdominal surgery when added to conventional multi-model intravenous analgesic technique.
The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane block in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing major upper abdominal surgery.
Patients and Methods:
A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 20-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane block and group II (60) will be subjected to morphine infusion at a rate of 0.03mg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.
Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
BMI above 40
Patients will be subjected to bilateral external oblique intercostal plane block
Procedure: Block group
Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h
Procedure: Morphine infusion
Patient will be subjected to bilateral external oblique intercostal plane block
Patients will be subjected to morphine infusion at a rate of 0.03mg/kg/h
Postoperative morphine requirements for 24 hours
Visual analogue score will be measured every 2 hours
Time frame: 24 hours postoperatively
Pain assessment
Visual analogue score will be assessed every 2hours postoperatively
Time frame: 24 hours postoperatively
Rescue analgesia
0.5 microgram/kg fentanyl will be given if VAS score more than 4
Time frame: 24 hours postoperatively
Side effects
Any side effect related to fentanyl or block
Time frame: 24 hours postoperatively
No study locations are listed for this record.
Plan to share: Yes — Data will be shared on request
Supporting information: Study protocol, Icf
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Alexandria University