Clinical trial NCT02285010: Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine
Official title: Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: pregabalin
postoperative pain
abdominal hysterectomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

Detailed description: The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

1. ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
2. Patient can use patient-controlled analgesia (IV PCA)

Exclusion Criteria:

1. History of drug allergy to gabapentinoid and related drug
2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
3. Renal disease (Creatinine Clearance \< 60), Liver disease, Seizure disorder and Psychiatric disorder

Primary outcomes:
measure: Post Operative Morphine Consumption
timeFrame: 6, 12, and 24 hours after operation
Secondary outcomes:
measure: Time to First Analgesia
timeFrame: 24 hours
measure: Pain Scores on the Visual Analog Scale
timeFrame: 24 hours
measure: Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 hours
measure: Number of Patients Evaluating Their Satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Taniga Kiatchai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available.
citation: Sahgal N, Banerjee A. Efficacy of pregabalin in acute postoperative pain: a meta-analysis. Br J Anaesth. 2011 Aug;107(2):274; author reply 275. doi: 10.1093/bja/aer207. No abstract available.
citation: Engelman E, Cateloy F. Efficacy and safety of perioperative pregabalin for post-operative pain: a meta-analysis of randomized-controlled trials. Acta Anaesthesiol Scand. 2011 Sep;55(8):927-43. doi: 10.1111/j.1399-6576.2011.02471.x. Epub 2011 Jun 27.