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Completed

NCT Number: NCT01090882

Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Gall Stones Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHCW NHS Trust

Coventry, Warwickshire, CV2 2DX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective laparoscopic cholecystectomy
  • 18 years old or over

Exclusion criteria

  • Emergency surgery
  • Under 18 year olds

Treatment and study plan

Bupivocaine

Drug

20ml 0.25% at beginning of operation

Other names: marcaine

0.9% normal saline solution

Drug

20ml 0.9% NaCl

Other names: marcaine

Primary outcomes

  1. VAS pain score

    Time frame: 1, 4, 8 hours after operation and at discharge

Secondary outcomes

  1. Time to ambulation

    Time frame: following the procedure

    The first time the patient gets out of bed and walks following the procedure

  2. Same day discharge

    Time frame: 24 hours

  3. VRS pain scores

    Time frame: Every 10 minutes in theatre recovery

    Immediately following the operation

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 23, 2010
Registry last updated
Jun 20, 2024

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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