Post-operative Pain
Conditions
Keywords
clonidine, bupivacaine, post-operative pain, arthrodesis, discectomy, local infiltration
Brief summary
The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.
Detailed description
Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. After verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150 μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and other pre and per operative medical data are noted. In the post-operative period, patients received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8 after surgery. Morphine rescue consumption is noted. Finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.
Interventions
DRUGBupivacaine
Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
DRUGClonidine
Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
Sponsors
St Joseph University, Beirut, Lebanon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* First (not recurrent) posterior spinal surgery at the operated site * American Society of Anesthesiologists class I or II (operative risk)
Exclusion criteria
* Allergy to local anesthetics or to clonidine * Pregnancy * Raynaud's syndrome * Thromboangiitis obliterans * History of substance abuse * Current treatment with corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area under curve | From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h | Pain is assessed on numeric rating scale (NRS) 8times/day during the first 3 days, 3times/day during the next 6days and one mean value during the night. The mean intensity of daily pain is obtained from the different values mentioned during day and night corrected by the duration covered by every value. It may vary from 0 to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under Curve (AUC) of pain | Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8 | The AUC during an interval (in days) is calculated by adding the different values of pain assessed during day and night multiplied by the duration (in hours) of sufferance from this amount of pain. The AUC during an interval is proportional to the mean intensity of pain suffered during the same interval. It is expressed in pain unit multiplied by hour |
| Daily rescue opiates consumption | From the day of surgery till the 3rd postoperative day | The unit of rescue opiates consumption equals the administration of 5mg of morphine subcutaneously. The minimum interval between 2 rescue opiates consumption is 6 hours. Thus, the rescue opiates consumption may vary from 0 to 4/day. |
| Global subjective patient satisfaction of post-operative wound pain control | Assessed at the end of follow-up on Day 8 | It may vary from 0 that means a total dissatisfaction to 100% that means a complete satisfaction |
Countries
Lebanon
Outcome results
None listed