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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03394001
• Other study ID #: FMASU R47/2017
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 3, 2018
• Last updated: January 5, 2018
• Start date: January 1, 2018
• Est. completion date: June 2018

Study information

• Verified date: January 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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
• Ketorolac tromethamine
20 mL of saline with 30 mg ketorolac

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rescue analgesia time	Time for first analgesia requirement	First 24 hours postoperatively
Secondary	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
Secondary	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