NCT06535581

Brief Summary

Background: The effect of the perfusion index (PI) as an indicator of postoperative pain was investigated. To this end, the presence of the perfusion index in predicting the need for analgesia and its effect in hypertensive patients were investigated. Researher aimed to investigate the change in perfusion index in the prediction of postoperative pain after laparotomic abdominal surgery. As a secondary aim, the results of the relative change in perfusion index in the presence of hypertensive disease were analysed. Methods: A total of 100 patients with ASA 1-3 with or without hypertension who were scheduled to undergo open abdominal surgery between 1 April 2023 and 30 November 2023 were included in the study. The relative variability of visual analogue scale (VAS) and PI in patients receiving postoperative analgesia was examined. The degree of prediction of postoperative pain by these variables after rescue analgesia was investigated. Hypertensive patients were analysed along with other patient groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 26, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

perfusion indexpostoperative painanaesthesia

Outcome Measures

Primary Outcomes (2)

  • PI value

    The correlation between the relative change in PI value and the relative change in VAS value after anesthesia induction and postoperative pain management was investigated.

    minutes 90

  • hypertension patient

    The relative change in PI value and the relative change in VAS value were compared in hypertensive patients and non-hypertensive patients.

    minutes 90

Secondary Outcomes (1)

  • complication

    minutes 90

Study Arms (2)

Group 1

hypertension patients

Procedure: surgery patient

group 2

non hypertension patients

Procedure: surgery patient

Interventions

patients with hypertension (group 2) and without (group 1) hypertension. The predictive ability of postoperative pain as a tool for measuring and assessing pain was examined by analysing the relative change in the Perfuston index.

Group 1group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

laparotomy abdominal surgery under general anesthesia.

You may qualify if:

  • American Society of Anesthesiologists physical statuses ranging from 1 to 3, who were scheduled to undergo laparotomy abdominal surgery under general anesthesia.

You may not qualify if:

  • Patients with difficult cooperation and heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Training and Research Hospital

Amasya, 05100, Turkey (Türkiye)

Location

Related Publications (3)

  • Bihani P, Pandey A, Jha M, Paliwal N, Jaju R, Solanki R. Comparing Perfusion Index and Visual Analogue Scores for Postoperative Pain Assessment Following Upper Limb Surgeries Under Supraclavicular Brachial Plexus Block: An Observational Study. Cureus. 2024 Mar 4;16(3):e55529. doi: 10.7759/cureus.55529. eCollection 2024 Mar.

    PMID: 38576659BACKGROUND
  • Kamel AAF, Medhat MM, Salem DAE, Naby SMA. Effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in nasal surgery: a randomized controlled trial. Patient Saf Surg. 2022 Aug 19;16(1):27. doi: 10.1186/s13037-022-00336-7.

    PMID: 35986325BACKGROUND
  • Elshal MM, Hasanin AM, Mostafa M, Gamal RM. Plethysmographic Peripheral Perfusion Index: Could It Be a New Vital Sign? Front Med (Lausanne). 2021 Oct 1;8:651909. doi: 10.3389/fmed.2021.651909. eCollection 2021.

    PMID: 34660615BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Medical Errors

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • harun duran, md

    Amasya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 2, 2024

Study Start

April 5, 2023

Primary Completion

November 1, 2023

Study Completion

June 1, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations