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

Phase 4

• Conditions: Anesthesia
• Interventions: Procedure: Wound infiltration; Drug: Ketorolac tromethamine; Drug: Lidocaine Hydrochloride

• Registration Number: NCT03394001
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-05
• Last Update Submitted: 2018-01-05
• Study First Posted: 2018-01-09
• Last Update Posted: 2018-01-09
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac tromethamine	Wound infiltration	Wound infiltration with Ketorolac
Lidocaine Hydrochloride	Wound infiltration	Wound infiltration with Lidocaine
Ketorolac tromethamine	Ketorolac tromethamine	Wound infiltration with Ketorolac
Lidocaine Hydrochloride	Lidocaine Hydrochloride	Wound infiltration with Lidocaine

Primary Outcome Measures

Name	Time	Method
Rescue analgesia time	First 24 hours postoperatively	Time for first analgesia requirement

Secondary Outcome Measures

Name	Time	Method
The total analgesic consumption	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.
Patient's pain score	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.

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt