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

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

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Wound infiltration; Drug: Lidocaine Hydrochloride; Drug: Ketorolac tromethamine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Ketorolac; Ketorolac Tromethamine
• Other Study ID Numbers: FMASU R47/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No