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

Association of Preoperative Pain Catastrophizing With Postoperative Pain After Lower Limb Trauma Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Other: Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Nepal
  • Koshi
    • Dharān Bāzār, Koshi, Nepal, 56700
      • BP Koirala Institute of Health Sciences (BPKIHS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between preoperative pain catastrophizing scale (PCS) scores with total tramadol consumption postoperatively at 24 hrs	Correlation between preoperative pain catastrophizing scale scores with total tramadol consumption postoperatively upto 24 hrs. 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.	24 hrs postoperatively
Correlation of preoperative pain catastrophizing scale (PCS) scores with risk factors for severe pain postoperatively	risk factors include: Age, gender, BMI, socio-economic condition, preoperative anxiety	24 hrs postoperatively

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2018
• Primary Completion (ACTUAL): August 16, 2019
• Study Completion (ACTUAL): September 3, 2019

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRC/1441/018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No