Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy

Study Overview
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Brief Summary
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The main goal of this study is to compare wound infiltration with ketorolac versus lidocaine for postoperative analgesia in total abdominal hystrectomy (TAH) operation.

Official Title
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Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy: a Prospective, Randomized, Double-blind Study.

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Wound infiltration
* Drug: Lidocaine Hydrochloride
* Drug: Ketorolac tromethamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I and II Planned for elective TAH with a Pfannenstiel incision Exclusion Criteria: Patients with the following criteria will be excluded from the study; ASA physical status more than II Body mass index (BMI)>35 kg/m2 Previous abdominal surgeries Malignancy Individuals with chronic pain A history of severe systemic disease A pre-existing neurological or psychiatric illness Known to be addict on alcohol or drugs Known allergy to the study drugs

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine Hydrochloride<br>Wound infiltration with Lidocaine | Procedure: Wound infiltration<br>* 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.<br>Drug: Lidocaine Hydrochloride<br>* 20 ml of 1% Lidocaine solution<br>* Other names: Lidocaine Hydrochloride; Lidocaine HCL 50mg/5 ml;|
| Active Comparator: Ketorolac tromethamine<br>Wound infiltration with Ketorolac | Procedure: Wound infiltration<br>* 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.<br>Drug: Ketorolac tromethamine<br>* 20 mL of saline with 30 mg ketorolac<br>* Other names: Adolor; Ketorolac tromethamine 30mg/2ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue analgesia time | Time for first analgesia requirement | First 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | First 24 hours postoperatively |