Pain, PostoperativeNCT03758560
Preoperative Pain Catastrophizing and Its Association With Postoperative Pain After Lower Limb Trauma Surgery
An observational study of Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire
- How many people
- 135 participants
- Where
- 1 siteNepal
- Study dates
- 16 Dec 2018to 3 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with lower limb musculo-skeletal trauma admitted in the orthopaedic unit of BPKIHS and planned for elective surgery.
Who may be able to join
- 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
Who cannot join
- Non- responders, Those unable to read and write; or Patients with known psychiatric disorder, Prior intake of pain medication, and Chronic pain.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, 56700
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaireOther
Patients will be asked to complete the scores based Nepali version of pain catastrophizing scale (PCS) questionnaire preoperatively
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 24 hours postoperatively
Secondary outcomes (2)
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.
Measured: 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
Measured: 24 hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start16 Dec 2018
- Primary completion16 Aug 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Asish Subedi, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758560
- Sponsor's protocol ID
- IRC/1441/018
- Status last verified
- Sep 2019
- First submitted
- 25 Nov 2018
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34371257
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative Pain Catastrophizing With Postoperative Pain After Lower Limb Trauma Surgery
- ClinicalTrials.gov ID
- NCT03758560
- Acronym / sponsor ID
- IRC/1441/018
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 16 Dec 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with lower limb musculo-skeletal trauma admitted in the orthopaedic unit of BPKIHS and planned for elective surgery.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Non- responders, Those unable to read and write; or Patients with known psychiatric disorder, Prior intake of pain medication, and Chronic pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnairePatients will be asked to complete the scores based Nepali version of pain catastrophizing scale (PCS) questionnaire preoperatively | Other | – |
Primary outcome
Correlation of preoperative pain catastrophizing scale (PCS) scores with maximum pain severity at 24 hrs post-operatively.
Time frame: 24 hours postoperatively
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."
2 secondary outcomes
Correlation between preoperative pain catastrophizing scale (PCS) scores with total tramadol consumption postoperatively at 24 hrs
Time frame: 24 hrs postoperatively
Correlation of preoperative pain catastrophizing scale (PCS) scores with risk factors for severe pain postoperatively
Time frame: 24 hrs postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Derived from this study: PubMed 34371257Subedi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of preoperative pain catastrophizing scale (PCS) scores with maximum pain severity at 24 hrs post-operatively. (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03758560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.