Can we reduce pain and improve mobility after keyhole surgery for removal of the gallbladder by enhancing intraoperative care?

Phase 3

Recruiting

• Conditions: cholelithiasis; post-operative pain; Surgery - Surgical techniques; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622001298707
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-06
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

All English-speaking patients 18 years and over undergoing elective laparoscopic cholecystectomy at participating institutions.

Exclusion Criteria

-Are unable to give written informed consent to take part in the study,
-Patients who require the use of a trained healthcare interpreter to be able to understand study information.
-Unable to carry out spirometry or mobility assessment
-Long term opioid use
-BMI > 35kg/m2
-Significant lung disease with FEV1 <1.25L
-Previous upper abdominal laparotomy suggestive of prolonged, complex upper abdominal surgery/ adhesiolysis
-Past abdominoplasty, abdominal wall reconstruction, component separation
-Known allergies to local anaesthetic or opioid agents.
-Known chronic pain syndrome
-Diagnosed neuromuscular disease
-Previous necrotizing pancreatitis
-Known stage 4 chronic kidney disease of eGFR 15-29ml/min.

Study & Design

• Study Type: Interventional
• Study Design: Not specified