Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

NCT ID: NCT05543785

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-30

Brief Summary

Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.

Detailed Description

This is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. The investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pressuerization on the postoperative analgesia.

All patients will receive spinal anesthesia aiming for at least T12-L1 level. Postoperative standard analgesia will be paracetamol and diclofenac, given for both groups.

Conditions

Postoperative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

control

will receive 50 ml normal saline in the intravenous regional cannula in the surgical limb with torniquet.

And receive intravenous 30 mg ketorolac diluted in 10 ml saline in the peripheral general circulation.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected

ketorolac

will receive 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml in the intravenous regional cannula in the surgical limb with torniquet.

And receive intravenous 10 ml saline in the peripheral general circulation.

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 30 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml will be injected

Interventions

Ketorolac

After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 30 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml will be injected

Intervention Type: DRUG

Control

After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected

Intervention Type: OTHER

Other Intervention Names

ketolac; Toradol; Biorolac; Saline without drugs

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists physical status I or II
• Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia

Exclusion Criteria

• Pregnant females
• Body mass index ≥ 35 kg/m2
• Allergy to ketorolac
• Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias
• Had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides
• Edema in the operated limb grade ≥ 3

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha AboZeid, MD

Role: STUDY_DIRECTOR

Mansoura University, Faculty of Medicine -

Locations

Mansoura University Hospitals

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maha AboZeid, MD

Role: CONTACT

mahazed@mans.edu.eg

02-01019216192

Moataz M Emara, MD, EDAIC

Role: CONTACT

mm.emara@mans.edu.eg

01064048848 ext. +20

Facility Contacts

Maha A Abozeid, MD

Role: primary

Mahazed@mans.edu.eg

00201019216192

Moataz M Emara, Md, EDAIC

Role: backup

mm.emara@mans.edu.eg

+201064048848

Other Identifiers

R.22.09.1832

Identifier Type: -

Identifier Source: org_study_id