Viewing Study NCT03758560



Ignite Creation Date: 2024-05-06 @ 12:25 PM
Last Modification Date: 2024-10-26 @ 12:58 PM
Study NCT ID: NCT03758560
Status: COMPLETED
Last Update Posted: 2019-09-09
First Post: 2018-11-25

Brief Title: Preoperative Pain Catastrophizing and Its Association With Postoperative Pain After Lower Limb Trauma Surgery
Sponsor: BP Koirala Institute of Health Sciences
Organization: BP Koirala Institute of Health Sciences

Study Overview

Official Title: Association of Preoperative Pain Catastrophizing With Postoperative Pain After Lower Limb Trauma Surgery
Status: COMPLETED
Status Verified Date: 2019-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 26 ml of hyperbaric bupivacaine 05 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None