Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285010
• Other study ID #: Si594/2014
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: August 2016

Study information

• Verified date: November 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
• Pregabalin
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Morphine Consumption	Cumulative morphine consumption in the first 24 hours is recorded from IV PCA	6, 12, and 24 hours after operation
Secondary	Time to First Analgesia	Time to first analgesia is recorded from IV PCA.	24 hours
Secondary	Pain Scores on the Visual Analog Scale	Pain score is evaluated by nurses using Numerical Rating Scale (NRS); Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome	24 hours
Secondary	Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability	Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire	24 hours
Secondary	Number of Patients Evaluating Their Satisfaction	Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.	24 hours