NCT03758560

Brief Summary

The Pain Catastrophizing Scale (PCS) is a psychometric tool to identify PC. A positive correlation between PCS scores and various pain outcomes has been reported in acute and chronic pain settings. Preoperative catastrophizing is associated with an increased intensity of postoperative pain and more analgesic consumption. Likewise, a recent meta-analysis revealed that PC is a strong predictor of persistent postsurgical pain. The Nepali version of PCS has been validated recently in patients with chronic pain. However, it has not been used in patients with acute pain. Therefore, our aim is to assess the relationship between preoperative Nepali PCS (N-PCS) scores and postoperative pain intensity and total opioid consumption in patients with musculoskeletal trauma planned for surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

December 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

November 25, 2018

Last Update Submit

September 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation of preoperative pain catastrophizing scale (PCS) scores with maximum pain severity at 24 hrs post-operatively.

    Correlation of preoperative pain catastrophizing scale scores with maximum pain severity at 24 hrs post-operatively. PCS consists of 13 items rated on a 5-point Likert scales from 0 (never) to 4 (all the time) points. The total score for the PCS is 52, with points more than 24 indicating a high level of catastrophizing. Worst or maximum pain intensity during the first 24 hours after surgery is assessed on an 11-point numerical rating scale (NRS). Pain is rated on a 0 to 11 NRS, with 0="no pain" or and 10=pain "as bad as you can imagine."

    24 hours postoperatively

Secondary Outcomes (2)

  • Correlation between preoperative pain catastrophizing scale (PCS) scores with total tramadol consumption postoperatively at 24 hrs

    24 hrs postoperatively

  • Correlation of preoperative pain catastrophizing scale (PCS) scores with risk factors for severe pain postoperatively

    24 hrs postoperatively

Interventions

Patients will be asked to complete the scores based Nepali version of pain catastrophizing scale (PCS) questionnaire preoperatively

Eligibility Criteria

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

Adult patients with lower limb musculo-skeletal trauma admitted in the orthopaedic unit of BPKIHS and planned for elective surgery.

You may qualify if:

  • Patients with traumatic lower-limb injury scheduled for lower-extremity surgery under spinal anaesthesia.
  • American Society of Anaesthesiologists physical status I or II, Age between 18 and 65 years of age

You may not qualify if:

  • Non- responders, Those unable to read and write; or Patients with known psychiatric disorder, Prior intake of pain medication, and Chronic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

Location

Related Publications (1)

  • Subedi A, Pokharel K, Sah BP, Chaudhary P. Association of preoperative pain catastrophizing with postoperative pain after lower limb trauma surgery. J Psychosom Res. 2021 Oct;149:110575. doi: 10.1016/j.jpsychores.2021.110575. Epub 2021 Jul 24.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 29, 2018

Study Start

December 16, 2018

Primary Completion

August 16, 2019

Study Completion

September 3, 2019

Last Updated

September 9, 2019

Record last verified: 2019-09

Locations