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the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Pregabalin 150mg

Placebo

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring pregabalin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

: This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery

Exclusion Criteria:

: Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

Sites / Locations

Mahmoud Maher

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Placebo group

Arm Description

patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery

patients will receive placebo 1 hour before surgery with a sip of water.

Outcomes

Primary Outcome Measures

Morphia dose

the total amount of rescue morphine received by patients for 24h postoperatively.

Secondary Outcome Measures

Postoperative pain

post operative VAS score

Full Information

NCT ID

NCT05083793

First Posted

October 6, 2021

Last Updated

October 6, 2021

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05083793

Brief Title

the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

Official Title

The Effect of Pregabalin on Post-operative Pain and Opioid Consumption in Spine Surgery, a Prospective, Randomized, Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study

Detailed Description

Aim of the work: The aim of our study is to compare the analgesic effect of pre-emptive oral pregabalin 150mg on acute postoperative pain and opioid consumption in spine surgery. Evaluated by visual analog scale (VAS) primary outcome measure is the total amount of rescue morphine received by patients for 24h postoperatively. secondary outcome measures include level of acute postoperative pain by VAS, and duration of hospital stay Patients and methods : This study will be carried out after being approved from the Medical Research Ethical Committee, Faculty of Medicine, Assiut University, Assiut, Egypt, and after obtaining a written informed consents from all participating patients. inclusion criteria: This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery Exclusion criteria : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

6. Conditions and Keywords

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

Postoperative Pain

Keywords

pregabalin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

care provider

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

patients will receive placebo 1 hour before surgery with a sip of water.

Intervention Type

Drug

Intervention Name(s)

Pregabalin 150mg

Other Intervention Name(s)

Pregabalin

Intervention Description

The effect of pregabalin on post-operative pain

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

patients will receive placebo one hour before operation

Primary Outcome Measure Information:

Title

Morphia dose

Description

the total amount of rescue morphine received by patients for 24h postoperatively.

Time Frame

24 hour postoperative

Secondary Outcome Measure Information:

Title

Postoperative pain

Description

post operative VAS score

Time Frame

24 hour postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: : This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery Exclusion Criteria: : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud Maher, MD

Organizational Affiliation

Assiut University Hospitals

Official's Role

Study Chair

Facility Information:

Facility Name

Mahmoud Maher

City

Assiut

ZIP/Postal Code

11174

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

make individual participant data (IPD) available to other researchers

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

Study protocol

IPD Sharing URL

https://pubmed.ncbi.nlm.nih.gov/15315511/

Citations:

PubMed Identifier

15315511

Citation

Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.

Results Reference

background

PubMed Identifier

16205916

Citation

Hindmarch I, Trick L, Ridout F. A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl). 2005 Dec;183(2):133-43. doi: 10.1007/s00213-005-0172-7. Epub 2005 Nov 9.

Results Reference

background

PubMed Identifier

27630927

Citation

Sebastian B, Talikoti AT, Nelamangala K, Krishnamurthy D. Effect of Oral Pregabalin as Preemptive Analgesic in Patients Undergoing Lower Limb Orthopedic Surgeries under Spinal Anaesthesia. J Clin Diagn Res. 2016 Jul;10(7):UC01-4. doi: 10.7860/JCDR/2016/18854.8081. Epub 2016 Jul 1.

Results Reference

background

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/15315511/

Description

Pregabalin pharmacology and its relevance to clinical practice

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the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

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