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Trial record 43 of 475 for:    KETOROLAC

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

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ClinicalTrials.gov Identifier: NCT03394001
Recruitment Status : Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Marwa Mostafa Mohamed Ali Mowafi, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Wound infiltration Drug: Lidocaine Hydrochloride Drug: Ketorolac tromethamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy: a Prospective, Randomized, Double-blind Study.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


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 Name: 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 Name: Adolor; Ketorolac tromethamine 30mg/2ml




Primary Outcome Measures :
  1. Rescue analgesia time [ Time Frame: First 24 hours postoperatively ]
    Time for first analgesia requirement


Secondary Outcome Measures :
  1. Patient's pain score [ Time Frame: First 24 hours postoperatively ]
    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.

  2. The total analgesic consumption [ Time Frame: First 24 hours postoperatively ]
    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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394001


Locations
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Egypt
Ain Shams University hospitals
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Marwa Mostafa Mohamed Ali Mowafi, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03394001     History of Changes
Other Study ID Numbers: FMASU R47/2017
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors