An interventional study of Xylocaine plus Dexamethasone and Xylocaine plus epinephrine in Dexamethasone, Lidocaine and Scalp Incision Infiltration, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
This study aimed to test the hypothesis that pre-emptive scalp infiltration with a steroid (dexamethasone) plus a local anesthetic (xylocaine) could achieve superior postoperative analgesic effects to a local anesthetic (xylocaine) plus epinephrine in adult patients undergoing a craniotomy.
Approximately 55-87% of patients undergoing craniotomy experience moderate to severe pain during the first 48 hours after surgery, which negatively influences their postoperative rehabilitation.
Recently, local infiltration of analgesia (LIA) has been widely performed clinically as a promising analgesic method that could avoid the side effects of analgesics but only has a short pain-free duration; researchers have clarified that the addition of dexamethasone to LIA could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries.
To date, no studies have evaluated the addition of dexamethasone to LIA for patients receiving craniotomy.
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received the incision site infiltration of 2% xylocaine plus dexamethasone.
Drug: Xylocaine plus Dexamethasone
Patients received the incision site infiltration of 2% xylocaine plus epinephrine.
Drug: Xylocaine plus epinephrine
Drug pages: Lidocaine · Dexamethasone
Patients received the incision site infiltration of 2% xylocaine plus dexamethasone.
Drug pages: Lidocaine · Epinephrine
Patients received the incision site infiltration of 2% xylocaine plus epinephrine.
Degree of pain
Degree of pain was measured using the Numerical Rating Scale after surgery (numeric rating scale (NRS); 0 = no pain, 10 = worst imaginable pain)
Time frame: 48 hours postoperatively
Total opioid consumption
Total postoperative opioid (fentanyl) consumption was recorded.
Time frame: 48 hours postoperatively
Mean arterial pressure
Mean arterial pressure was measured during induction and every fifteen minutes after that.
Time frame: Till the end of surgery (Up to 2 hours)
Heart rate
Heart rate was measured during induction and every fifteen minutes after that
Time frame: Till the end of surgery (Up to 2 hours)
Time to first postoperative analgesic request
The time to the first postoperative analgesic request was recorded from the end of surgery till the first dose of fentanyl administered.
Time frame: 48 hours postoperatively
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting was recorded.
Time frame: 48 hours postoperatively
Degree of patient satisfaction
Degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Time frame: 48 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Dexamethasone