Efficacy of Pre-Emptive Analgesia with Pregabalin and Celecoxib in Major Maxillofacial Surgery: A Randomized Double Blind Placebo Controlled Clinical Pilot Study
The purpose of this study was to obtain pilot data on the efficacy of pre-emptive analgesia with Pregabalin and Celecoxib on immediate and extended post-operative intravenous and oral narcotic consumption and perceived pain in subjects undergoing maxillomandibular advancement surgery for obstructive sleep apnea.
Patients and Methods
This was a prospective, randomized, double-blind placebo controlled study of healthy adult subjects (ages 18-60 years, ASA I-III) undergoing elective maxillomandibular advancement surgery for polysomnogram confirmed obstructive sleep apnea. Patients who voluntarily accepted to be enrolled in this study were randomly and blindly entered into either the study or placebo group. The groups were administered either masked one-time pre-operative dose of 150 mg of Pregabalin and 400 mg of Celecoxib (Study Group) or lactose (Placebo Group), all in identical unidentifiable gelatin capsules, by mouth one hour prior to surgery. In the post-operative period, an intravenous morphine patient-controlled analgesia (PCA) machine was used to determine the amount of narcotic administered per 4 hour interval during the immediate 48 hour post-operative hospital period. A daily pain and narcotic log was provided for a seven day post-hospital period. Daily narcotic consumption and visual analog scale (VAS) for pain was recorded by the patient. Statistical significance between group means was determined by the Mann Whitney U test and found significant at the p < .05 level.
Results
Six subjects (N = 12) were included in each group with no significant difference in age between the Pregabalin/Celecoxib and Placebo (43.4 +/- 3.4 versus 42.7 +/- 2.7; P = .4). There was a statistically significant difference between the Pregabalin/Celecoxib and Placebo groups in average intravenous morphine consumption per 4 hour interval (6.0 mg +/- 5.9 mg versus 9.3 mg +/- 7.9 mg, p < .05) in the immediate 48 hour post-operative hospital period. In the extended seven day post-operative period, there was a statistically significant difference between the Pregabalin/Celecoxib and Placebo groups for average narcotic pill consumption per day (2.9 +/- 2.9 versus 6.8 +/- 1.8, p < .05) and average daily VAS scores (4.3 +/- 3.5 versus 5.5 +/- 5.0, p < .05).
Conclusion
The data from this pilot study revealed that the pre-emptive analgesic effect of a one-time pre-operative oral dose of both Pregabalin and Celecoxib prior to major maxillofacial surgery produced, in immediate post-operative, a statistically significant decrease in average intravenous morphine consumption, and, in the extended seven day post-operative period, a decrease in average narcotic pill consumption and average perceived pain.