Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy.

NCT ID: NCT05543668

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2023-06-01

Brief 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 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.

2. To examine baseline demographic, clinical, psycho-behavioural features and intraoperative factors in relation to dynamic moderate to severe pain after LC.

3. 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.

Conditions

Pain, Postoperative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

preexisting preoperative chronic pain

Patients with preexisting preoperative chronic pain (more than 3 months duration).

No interventions assigned to this group

preexisting preoperative sub-acute pain

Patients with preexisting preoperative sub-acute pain (less than 3 months duration).

No interventions assigned to this group

No pain preoperatively

Patients without preexisting preoperative pain.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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)
• Choledocholithiasis
• Features of obstructive jaundice.
• Unable to communicate (eg. Language barrier or deaf)
• Open cholecystectomy or laparoscopic cholecystectomy converted to open cholecystectomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

BISHAL NEPALI

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asish Subedi, MD

Role: STUDY_CHAIR

B.P. Koirala Institute of Health Sciences

Locations

B.P. Koirala Institute of Health Sciences

Dharān, Province O1, Nepal

Countries

Nepal

Other Identifiers

IRC/2283/022

Identifier Type: -

Identifier Source: org_study_id