Pain, PostoperativeNCT05543668
Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy.
An observational study of Pain, Postoperative, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
Despite advancement in perioperative pain management, more than half of the patients still report moderate-severe pain after surgery. Among several risk factors, pre-existing pain has consistently been shown to predict postoperative severe pain.If one can predict the patients who will experience more post-operative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- How many people
- 195 participants
- Where
- 1 siteNepal
- Study dates
- 16 Sep 2022to 1 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are 18 years or more than 18 years of age, ASA PS 1, 2 and 3, scheduled for elective laparoscopic cholecystectomy.
Who may be able to join
- All patients undergoing laparoscopic cholecystectomy.
- Age group (more than or equal to 18 years)
- ASA physical status 1, 2 and 3.
- Ability to use NPRS scale, PROMIS scale, pain catastrophizing scale, APAIS, neuroticism EPQRS scale, and to understand and follow simple instructions.
Who cannot join
- All patient with
- Not willing to participate in the study
- Severe Neurological and Psychiatric disorder(eg. dementia)
- Pregnant women
- Acute cholecystitis managed conservatively.
- Cognitive impairments (lack of capacity to provide informed consent)
Show all 10Show fewer
- Choledocholithiasis
- Features of obstructive jaundice.
- Unable to communicate (eg. Language barrier or deaf)
- Open cholecystectomy or laparoscopic cholecystectomy converted to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
Nepal1 site
B.P. Koirala Institute of Health Sciences
Dharān, Province O1, 56700
About this study
Official title: Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy:a Prospective Observational Study.
Despite advancement in perioperative pain management, more than half of the patients still report moderate-severe pain after surgery. Among several risk factors, pre-existing pain has consistently been shown to predict postoperative severe pain.If one can predict the patients who will experience more post-operative pain, then a more aggressive pain management strategy can be adopted perioperatively. This would improve patient satisfaction and prevent poor outcomes such as chronic pain after surgery. Therefore, our primary aim is to find out whether presence of pre-existing preoperative pain would predict moderate-severe acute pain after laparoscopic cholecystectomy. Moreover, we plan to use Patient Reported Outcomes Measurement Information System (PROMIS) scale to assess preoperative pain intensity and pain-related behaviors.
Primary \&Secondary Objectives:
Read more
Primary objectives To investigate the association between preexisting preoperative pain (more than 3 months duration) and postoperative moderate-severe acute pain after laparoscopic cholecystectomy.
Secondary objectives .1. To investigate the association between preoperative PROMIS(patient reported outcome measurement and information system) domain (PROMIS pain intensity score, PROMIS pain interference score, PROMIS pain behavioural score) and postoperative moderate-severe acute pain after LC.
- To examine baseline demographic, clinical, psycho-behavioural features and intraoperative factors in relation to dynamic moderate to severe pain after LC.
- To identify perioperative predictors for acute postsurgical pain. 4. To find out the incidence of shoulder tip pain after LC.
Read the detailed description
Patients who are 18 years of age or more, of ASA 1, 2 and 3, and scheduled for elective laparoscopic cholecystectomy under general anaesthesia will be enrolled in this prospective observational study. Perioperative anaesthesia management will be standardized for all patients.
Variables such as age, sex, preexisting preoperative pain (chronic or subacute), preoperative PROMIS pain intensity, PROMIS behavior, PROMIS interference, PROMIS depression, PROMIS sleep disturbance, APAIS score, catastrophizing pain score, neuroticism (EPQRS score), preoperative pain sensitivity, an expectation of the postoperative pain and intraoperative surgical variables will be recorded.
- Conditions
- Pain, Postoperative
- Keywords
- postoperative pain, dynamic moderate to severe pain, laprascopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preexisting preoperative chronic pain | Patients with preexisting preoperative chronic pain (more than 3 months duration). | |
| preexisting preoperative sub-acute pain | Patients with preexisting preoperative sub-acute pain (less than 3 months duration). | |
| No pain preoperatively | Patients without preexisting preoperative pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of acute moderate to severe postoperative pain.
numerical pain rating scale (NPRS) more than or equal to 4.
Measured: up to 24 hours postoperatively.
Secondary outcomes (2)
incidence of shoulder tip pain.
in 24 hours
Measured: up to 24 hours postoperatively.
Risk factors associated with moderate to severe pain after laparoscopic cholecystectomy
demographic, clinical, psycho-behavioural, preoperative and intraoperative variables
Measured: up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start16 Sep 2022
- Primary completion10 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BISHAL NEPALI, B.P. Koirala Institute of Health Sciences
- Investigators
- Asish Subedi, MD, Study chair, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543668
- Sponsor's protocol ID
- IRC/2283/022
- Status last verified
- Jul 2023
- First submitted
- 14 Sep 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy:a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05543668
- Acronym / sponsor ID
- IRC/2283/022
- Conditions
- Pain, Postoperative
- Keywords
- postoperative pain, dynamic moderate to severe pain, laprascopic cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 Sep 2022 (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.
Despite advancement in perioperative pain management, more than half of the patients still report moderate-severe pain after surgery. Among several risk factors, pre-existing pain has consistently been shown to predict postoperative severe pain.If one can predict the patients who will experience more post-operative pain, then a more aggressive pain management strategy can be adopted perioperatively. This would improve patient satisfaction and prevent poor outcomes such as chronic pain after surgery. Therefore, our primary aim is to find out whether presence of pre-existing preoperative pain would predict moderate-severe acute pain after laparoscopic cholecystectomy. Moreover, we plan to use Patient Reported Outcomes Measurement Information System (PROMIS) scale to assess preoperative pain intensity and pain-related behaviors.
Primary \&Secondary Objectives:
Primary objectives To investigate the association between preexisting preoperative pain (more than 3 months duration) and postoperative moderate-severe acute pain after laparoscopic cholecystectomy.
Secondary objectives .1. To investigate the association between preoperative PROMIS(patient reported outcome measurement and information system) domain (PROMIS pain intensity score, PROMIS pain interference score, PROMIS pain behavioural score) and postoperative moderate-severe acute pain after LC.
- To examine baseline demographic, clinical, psycho-behavioural features and intraoperative factors in relation to dynamic moderate to severe pain after LC.
- To identify perioperative predictors for acute postsurgical pain. 4. To find out the incidence of shoulder tip pain after LC.
Detailed description
Patients who are 18 years of age or more, of ASA 1, 2 and 3, and scheduled for elective laparoscopic cholecystectomy under general anaesthesia will be enrolled in this prospective observational study. Perioperative anaesthesia management will be standardized for all patients.
Variables such as age, sex, preexisting preoperative pain (chronic or subacute), preoperative PROMIS pain intensity, PROMIS behavior, PROMIS interference, PROMIS depression, PROMIS sleep disturbance, APAIS score, catastrophizing pain score, neuroticism (EPQRS score), preoperative pain sensitivity, an expectation of the postoperative pain and intraoperative surgical variables will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preexisting preoperative chronic pain | – | –Patients with preexisting preoperative chronic pain (more than 3 months duration). |
| preexisting preoperative sub-acute pain | – | –Patients with preexisting preoperative sub-acute pain (less than 3 months duration). |
| No pain preoperatively | – | –Patients without preexisting preoperative pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are 18 years or more than 18 years of age, ASA PS 1, 2 and 3, scheduled for elective laparoscopic cholecystectomy.
Key inclusion criteria (4 listed)
- All patients undergoing laparoscopic cholecystectomy.
- Age group (more than or equal to 18 years)
- ASA physical status 1, 2 and 3.
- Ability to use NPRS scale, PROMIS scale, pain catastrophizing scale, APAIS, neuroticism EPQRS scale, and to understand and follow simple instructions.
Key exclusion criteria (10 listed)
- All patient with
- Not willing to participate in the study
- Severe Neurological and Psychiatric disorder(eg. dementia)
- Pregnant women
- Acute cholecystitis managed conservatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of acute moderate to severe postoperative pain.
Time frame: up to 24 hours postoperatively.
numerical pain rating scale (NPRS) more than or equal to 4.
2 secondary outcomes
incidence of shoulder tip pain.
Time frame: up to 24 hours postoperatively.
Risk factors associated with moderate to severe pain after laparoscopic cholecystectomy
Time frame: up to 24 hours 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 19 Jul 2023.
- 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.
Asish Subedi, MD study chair
B.P. Koirala Institute of Health Sciences
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 4 inclusion and 10 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 19 Jul 2023. 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?
Occurrence of acute moderate to severe postoperative pain. (time frame: up to 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2023.