Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Official title

Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study

Overview

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.

Interventions

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

Primary outcome measures

• The postoperative analgesic duration [Time frame: within 24 hours after the surgery]

Secondary outcome measures (5)

• Postoperative pain at rest [Time frame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery]
• Postoperative pain at movement [Time frame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery]
• Total postoperative analgesic consumption [Time frame: within the first 24 hours after surgery]
• time to sensory recovery from spinal anesthesia [Time frame: through the intraoperative or postoperative care unit]
• time to motor recovery from spinal anesthesia [Time frame: through the intraoperative or postoperative care unit]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Egypt · 1 center

• Mansoura University Hospitals — Al Mansurah

Identifiers

NCT: NCT05543785 · R.22.09.1832

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗