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Completed

NCT Number: NCT05543668

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

B.P. Koirala Institute of Health Sciences

Dharān, Province O1, 56700, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. incidence of shoulder tip pain.

    Time frame: up to 24 hours postoperatively.

    in 24 hours

  2. Risk factors associated with moderate to severe pain after laparoscopic cholecystectomy

    Time frame: up to 24 hours postoperatively

    demographic, clinical, psycho-behavioural, preoperative and intraoperative variables

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2022
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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