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Preemptive Analgesia of Gabapentoids in Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT04775992
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
SALAH EL-TALLAWY, King Saud University

Study Description
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Brief Summary:
To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery

Condition or disease Intervention/treatment
Acute Postoperative Pain Other: gabapentoids

Detailed Description:
Computer search for all studies used preoperative gabapentoids versus no gabapentoids in orthopedic surgery during the last 10 years (from 2011 - 2020)
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Preemptive Analgesia of Gabapentoids After Major Orthopedic Surgery: Systematic Review and Meta Analysis
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
preemptive group
patients in this group will receive preoperative gabapentoids
 Other: gabapentoids
Preemptive analgesia
control group
patients in this group will not receive gabapentoids
 Other: gabapentoids
Preemptive analgesia


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain score on rest [ Time Frame: every hour for the first 24 hours ]
    Pain score by VAS on rest

  2. Postoperative pain during movement [ Time Frame: every hour for the first 24 hours ]
    Pain score by VAS during movements


Secondary Outcome Measures :
  1. Worst pain score [ Time Frame: during the first 24 hours ]
    Highest pain score

  2. Least pain score [ Time Frame: during the first 24 hours ]
    Lowest pain score

  3. Time spend in severe pain [ Time Frame: during the first 24 hours ]
    how many hours the patients complaint of severe pain

  4. Patient's satisfaction [ Time Frame: during the first 24 hours ]
    Satisfaction by the quality of analgesia


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all included RCT
Criteria

Inclusion Criteria:

  • RCT, during last 10 years, involving orthopedic surgery

Exclusion Criteria:

  • non randomized trials, unavailable study data
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: SALAH EL-TALLAWY, Professor and Consultant - Anesthesia and Pain Management, King Saud University
ClinicalTrials.gov Identifier: NCT04775992    
Other Study ID Numbers: KSU
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SALAH EL-TALLAWY, King Saud University:
acute postoperative pain
Preemptive analgesia
Orthopedic surgery
Preoperative gabapentoids
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations