A Phase 4 interventional study of Wound infiltration and Lidocaine Hydrochloride in Anesthesia, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.
Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 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:
Patients with the following criteria will be excluded from the study;
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wound infiltration with Lidocaine
Procedure: Wound infiltration · Drug: Lidocaine Hydrochloride
Wound infiltration with Ketorolac
Procedure: Wound infiltration · Drug: Ketorolac tromethamine
Before skin closure,the subcutaneous tissue and skin all around the wound will be infiltrated by 20 mL of the drug then closure of the skin will be done.
20 ml of 1% Lidocaine solution
Also known as: Lidocaine Hydrochloride; Lidocaine HCL 50mg/5 ml
20 mL of saline with 30 mg ketorolac
Also known as: Adolor; Ketorolac tromethamine 30mg/2ml
Rescue analgesia time
Time for first analgesia requirement
Time frame: First 24 hours postoperatively
Patient's pain score
Pain score will be done by visual analog scale (VAS) (minimum 0 = no pain, while maximum 10 cm = worst possible pain). Pain score will be recorded just after extubation (taken as 0 h) and after 1, 2, 4, 6, 12, 18 and 24 h later. Patients will be instructed about the usage of VAS scalebefore the operation.
Time frame: First 24 hours postoperatively
The total analgesic consumption
Postoperative analgesia will be provided with intramuscular (IM) meperidine 50 mg to both groups when the VAS score is ≥4. The total meperidine consumption will be recorded.
Time frame: First 24 hours postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2018 (actual). Primary completion is estimated for Jun 2018, 5 months after the start.
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Ketorolac Tromethamine