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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03394001
Enrollment
80
Registered
2018-01-09
Start date
2018-01-01
Completion date
2018-06-30
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

PROCEDUREWound 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.

DRUGLidocaine Hydrochloride

20 ml of 1% Lidocaine solution

DRUGKetorolac tromethamine

20 mL of saline with 30 mg ketorolac

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rescue analgesia timeFirst 24 hours postoperativelyTime for first analgesia requirement

Secondary

MeasureTime frameDescription
Patient's pain scoreFirst 24 hours postoperativelyPain 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.
The total analgesic consumptionFirst 24 hours postoperativelyPostoperative 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026