Preoperative Pain Catastrophizing and Its Association With Postoperative Pain After Lower Limb Trauma Surgery

NCT ID: NCT03758560

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-16

Study Completion Date

2019-09-03

Brief Summary

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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.

Detailed Description

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After approval from Institute Review Committee, we will assess eligibility of patients admitted in-patient-unit of orthopaedic ward planned for lower limb trauma surgery under spinal anesthesia. Recruited patients will be counseled and informed about the study and information sheet and consent form provided. Will obtain consent from the participant. patients will be asked to complete N- PCS questionnaire preoperatively a night before surgery in patient unit. On arrival to the operating room, standard monitoring will be applied. All the patients will receive spinal anaesthesia with 2.6 ml of hyperbaric bupivacaine (0.5%) and fentanyl 20 µg. NRS scale will be used to assess the intensity of their pain postoperatively on arrival to Post-anesthesia care unit, at 2, 4, 6, 12 h and 24 h after the end of surgery. One gram paracetamol IV and Ketorolac 30 mg IV will be given at the end of surgery and continued at 6 and 8 h intervals postoperatively. If the Numeric rating scale (NRS) for pain is \> 3 at rest, tramadol 50 mg IV bolus administered, and repeated at 10 min intervals until NRS was ≤ 3 for the first 24 h. Patients will be asked to rate their worst or maximum pain intensity during the first 24 hours after surgery, on an 11-point numerical rating scale. Socio-demographic variables (age, BMI, ethnicity, gender, socio-economic status, occupation and education), preoperative anxiety of the participant will be recorded.

Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr Asish Subedi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type DERIVED
PMID: 34371257 (View on PubMed)

Other Identifiers

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IRC/1441/018

Identifier Type: -

Identifier Source: org_study_id

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