Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

Gall Stones Clinical Trial

Official title:

Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090882
• Other study ID #: UHCW 1
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: October 2009

Study information

• Verified date: June 2024
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.

Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective laparoscopic cholecystectomy

• 18 years old or over

Exclusion Criteria:

• Emergency surgery

• Under 18 year olds

Related Conditions & MeSH terms

• Gall Stones
• Gallstones

Intervention

Drug:
• Bupivocaine
20ml 0.25% at beginning of operation
• 0.9% normal saline solution
20ml 0.9% NaCl

Locations

Country	Name	City	State
United Kingdom	UHCW NHS Trust	Coventry	Warwickshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain score		1, 4, 8 hours after operation and at discharge
Secondary	Time to ambulation	The first time the patient gets out of bed and walks following the procedure	following the procedure
Secondary	Same day discharge		24 hours
Secondary	VRS pain scores	Immediately following the operation	Every 10 minutes in theatre recovery