Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

NCT05543785 | Recruiting

• 1 other identifier: R.22.09.1832
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute

Keywords

ketorolac; randomized controlled trial; intravenous regional anesthesia; lower limb; orthopedic surgeries

Outcome Measures

Primary Outcomes (1)

• The postoperative analgesic duration

  the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient

  within 24 hours after the surgery

Secondary Outcomes (5)

• Postoperative pain at rest

  at 2, 4, 6, 12, 24 hours after 24 hours after surgery

• Postoperative pain at movement

  at 2, 4, 6, 12, 24 hours after 24 hours after surgery

• Total postoperative analgesic consumption

  within the first 24 hours after surgery

• time to sensory recovery from spinal anesthesia

  through the intraoperative or postoperative care unit

• time to motor recovery from spinal anesthesia

  through the intraoperative or postoperative care unit

Other Outcomes (3)

• superficial vnous thrombophilibitis

  intraoperative period

• postoperative bleeding tendency

  over the first 24 hours after surgery

• wound healing

  postoperative till the time to remove all wound sutures

Study Arms (2)

control

PLACEBO COMPARATOR

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.

Other: Control

ketorolac

ACTIVE COMPARATOR

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.

Drug: Ketorolac

Interventions

Ketorolac 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

Also known as: ketolac, Toradol, Biorolac

ketorolac

Control OTHER

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

Also known as: Saline without drugs

control

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Sodium Chloride; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maha AboZeid, MD

  Mansoura University, Faculty of Medicine -

  STUDY DIRECTOR

Central Study Contacts

Maha AboZeid, MD

CONTACT

02-01019216192; mahazed@mans.edu.eg

Moataz M Emara, MD, EDAIC

CONTACT

01064048848; mm.emara@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: An anesthetist, not involved in the study, was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drugs. The patient and the data collectors (anesthesia resident) does not know the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

EG (1)