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

Primary Purpose

Post Operative Pain

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

placebo

Pregabalin

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring pregabalin, postoperative pain, abdominal hysterectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Pregabalin

Arm Description

Placebo in capsule is prescribed to the patient 60 min prior to the surgery.

Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Outcomes

Primary Outcome Measures

Post Operative Morphine Consumption

Cumulative morphine consumption in the first 24 hours is recorded from IV PCA

Secondary Outcome Measures

Time to First Analgesia

Time to first analgesia is recorded from IV PCA.

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

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

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.

Full Information

NCT ID

NCT02285010

First Posted

October 31, 2014

Last Updated

November 27, 2018

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02285010

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

Keywords

pregabalin, postoperative pain, abdominal hysterectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo in capsule is prescribed to the patient 60 min prior to the surgery.

Arm Title

Pregabalin

Arm Type

Active Comparator

Arm Description

Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

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.

Primary Outcome Measure Information:

Title

Post Operative Morphine Consumption

Description

Cumulative morphine consumption in the first 24 hours is recorded from IV PCA

Time Frame

6, 12, and 24 hours after operation

Secondary Outcome Measure Information:

Title

Time to First Analgesia

Description

Time to first analgesia is recorded from IV PCA.

Time Frame

24 hours

Title

Pain Scores on the Visual Analog Scale

Description

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

Time Frame

24 hours

Title

Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability

Description

Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire

Time Frame

24 hours

Title

Number of Patients Evaluating Their Satisfaction

Description

Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine Patient can use patient-controlled analgesia (IV PCA) Exclusion Criteria: History of drug allergy to gabapentinoid and related drug History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taniga Kiatchai, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

24051389

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.

Results Reference

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PubMed Identifier

21757554

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.

Results Reference

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PubMed Identifier

21707548

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.

Results Reference

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

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