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

Pain, Postoperative Clinical Trial

Official title:

Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy:a Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05543668
• Other study ID #: IRC/2283/022
• Status: Completed
• Start date: September 16, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 1, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative

Locations

Country	Name	City	State
Nepal	B.P. Koirala Institute of Health Sciences	Dharan Bazar	Province O1

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	Occurrence of acute moderate to severe postoperative pain.	numerical pain rating scale (NPRS) more than or equal to 4.	up to 24 hours postoperatively.
Secondary	incidence of shoulder tip pain.	in 24 hours	up to 24 hours postoperatively.
Secondary	Risk factors associated with moderate to severe pain after laparoscopic cholecystectomy	demographic, clinical, psycho-behavioural, preoperative and intraoperative variables	up to 24 hours postoperatively