A Phase 2 interventional study of Bupivacaine 0.25% in Postoperative Pain, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Assiut University · Phase 2, Interventional, and Prevention
Good quality of postoperative analgesia would lead to attenuate or prevent the adverse effects on the common functions of the immune system. We compared the effect of epidural analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines following malignant urological surgery.
Study groups: 60 patients were included in the study randomly allocated into two groups of 30 patients. Rectus sheath group (RSB): Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia. Control group: the patients did not receive any intervention after anaesthesia induction.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia.
Exclusion criteria:
Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.
Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia
Drug: Bupivacaine 0.25%
Control group: the patients did not receive any intervention after anaesthesia induction.
Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia
Also known as: Plain marcaine
cumulative opioid consumption
study the effect of RSB on cumulative opioid consumption at 24 hours
Time frame: 24 hours postoperative
Numerical rating scale (NRS)
evaluate postoperative pain intensity by NRS
Time frame: 24 hours postoperative
time to first anlgesic request
the first time receiving IV-PCA bolus injection
Time frame: 24 hours postoperative
serum levels of TNF-α
Proinflamatory cytokines
Time frame: at 24 hours postoperative
Serum level of IL-6
Proinflamatory cytokines
Time frame: at 24 hours postoperative
Plan to share: Undecided
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assiut University