Postoperative Pain, Acute
Conditions
Keywords
ketorolac, randomized controlled trial, intravenous regional anesthesia, lower limb, orthopedic surgeries
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.
Interventions
DRUGKetorolac
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
OTHERControl
After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The postoperative analgesic duration | within 24 hours after the surgery | the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain at rest | at 2, 4, 6, 12, 24 hours after 24 hours after surgery | 0-10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain. |
| Postoperative pain at movement | at 2, 4, 6, 12, 24 hours after 24 hours after surgery | 0-10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain. Movement will be standardized as 10 cm elevation of the surgical limb off the bed. |
| Total postoperative analgesic consumption | within the first 24 hours after surgery | total amount of fentanyl as requested by the patient |
| time to sensory recovery from spinal anesthesia | through the intraoperative or postoperative care unit | time to receovery of pin brick sensation at S1 |
| time to motor recovery from spinal anesthesia | through the intraoperative or postoperative care unit | time to modified Bromage score 0 |
Countries
Egypt
Contacts
CONTACTMaha AboZeid, MD
CONTACTMoataz M Emara, MD, EDAIC
STUDY_DIRECTORMaha AboZeid, MD
Mansoura University, Faculty of Medicine -
Outcome results
None listed