Clinical trial NCT05543785: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain, Acute
Keywords: ketorolac
randomized controlled trial
intravenous regional anesthesia
lower limb
orthopedic surgeries
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The postoperative analgesic duration
timeFrame: within 24 hours after the surgery
Secondary outcomes:
measure: Postoperative pain at rest
timeFrame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery
measure: Postoperative pain at movement
timeFrame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery
measure: Total postoperative analgesic consumption
timeFrame: within the first 24 hours after surgery
measure: time to sensory recovery from spinal anesthesia
timeFrame: through the intraoperative or postoperative care unit
measure: time to motor recovery from spinal anesthesia
timeFrame: through the intraoperative or postoperative care unit
Other outcomes:
measure: superficial vnous thrombophilibitis
timeFrame: intraoperative period
measure: postoperative bleeding tendency
timeFrame: over the first 24 hours after surgery
measure: wound healing
timeFrame: postoperative till the time to remove all wound sutures
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
Study officials:
affiliation: Mansoura University, Faculty of Medicine -
name: Maha AboZeid, MD
role: STUDY_DIRECTOR
References: