Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01090882

Enrollment

128

Registered

2010-03-23

Start date

2009-07-31

Completion date

2009-10-31

Last updated

2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gall Stones

Keywords

Local anaesthetic, Laparoscopic cholecystectomy, Pain scores, Bupivocaine, Day case surgery

Brief 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.

Interventions

DRUGBupivocaine

20ml 0.25% at beginning of operation

DRUG0.9% normal saline solution

20ml 0.9% NaCl

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Elective laparoscopic cholecystectomy * 18 years old or over

Exclusion criteria

* Emergency surgery * Under 18 year olds

Design outcomes

Primary

Measure	Time frame
VAS pain score	1, 4, 8 hours after operation and at discharge

Secondary

Measure	Time frame	Description
Time to ambulation	following the procedure	The first time the patient gets out of bed and walks following the procedure
Same day discharge	24 hours	—
VRS pain scores	Every 10 minutes in theatre recovery	Immediately following the operation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026