The Effect of Pregabalin on the Spinal Anesthesia

Sponsor

Kyungpook National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02690506

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it was reported that premedication of pregabalin before general anesthesia is effective to reduce postoperative pain. Up to date, there is no study about the effect of premedication of pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the effect of premedication of pregabalin on the spinal anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Block	Drug: Placebo Drug: Pregabalin	N/A

Detailed Description

In this study, investigators investigate the effect of premedication of pregabaline 150 mg on the spinal anesthesia. Two hours before spinal anesthesia, placebo pill was administered to patients in the group C and pregabalin 150 mg was administered to patients in the group P, respectively. Time for the onset of blockade, cephalad level of analgesia and duration of analgesia were measured.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

The Effect of Pregabalin on the Spinal Anesthesia: Randomized Controlled Placebo Study

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group C Oral placebo pill was administered 2 hours before anesthesia	Drug: Placebo
Active Comparator: Group P Oral pregabalin 150 mg was administered 2 hours before anesthesia	Drug: Pregabalin

Arm

Intervention/Treatment

Placebo Comparator: Group C

Oral placebo pill was administered 2 hours before anesthesia

Drug: Placebo

Active Comparator: Group P

Oral pregabalin 150 mg was administered 2 hours before anesthesia

Drug: Pregabalin

Outcome Measures

Primary Outcome Measures

Duration of spinal anesthesia [24 hours after spinal anesthesia]
Duration of spinal anesthesia was measured 24 after spinal anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of American Society of Anaesthesiologists Grades I and II

Exclusion Criteria:

Patients with infection at the puncture site, coagulopathy, having true hypersensitivity to drugs used, diabetes and hypertension, psychiatric and neurological diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyungpook National University Hospital	Daegu		Korea, Republic of	700-721

Sponsors and Collaborators

Kyungpook National University Hospital

Investigators

Principal Investigator: Younghoon Jeon, Dr, Kyungpook National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Younghoon Jeon, Professor, Kyungpook National University Hospital

ClinicalTrials.gov Identifier:

NCT02690506

Other Study ID Numbers:

2014-05-027

First Posted:

Feb 24, 2016

Last Update Posted:

May 18, 2016

Last Verified:

May 1, 2016

Keywords provided by Younghoon Jeon, Professor, Kyungpook National University Hospital

pregabalin

spinal anesthesia

Additional relevant MeSH terms:

Pregabalin

Study Results

No Results Posted as of May 18, 2016