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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758560
• Other study ID #: IRC/1441/018
• Status: Completed
• Start date: December 16, 2018
• Est. completion date: September 3, 2019

Study information

• Verified date: September 2019
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 3, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• 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

Locations

Country	Name	City	State
Nepal	BP Koirala Institute of Health Sciences (BPKIHS)	Dharan Bazar	Koshi

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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