Intraperitoneal Techniques of Local Anaesthesia During La... | NCT01090882

Studies
Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

NCT01090882

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Status

Completed

Last Update Posted

Jun 20, 2024Actual

Enrollment

128Actual

Phase

Not Applicable

Conditions

Gall Stones

Interventions

Bupivocaine
0.9% normal saline solution

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Mar 18, 2010

First Submission Date that Met QC Criteria

Mar 22, 2010

First Posted Date

Mar 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2024

Last Update Posted Date

Jun 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Sham Comparator	Sham wash, sham injection	Drug: 0.9% normal saline solution
Subperitoneal injection	Experimental	Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder	Drug: Bupivocaine
Topical LA	Active Comparator	Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm	Drug: Bupivocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivocaine	Drug	20ml 0.25% at beginning of operation	Subperitoneal injection Topical LA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to ambulation	The first time the patient gets out of bed and walks following the procedure	following the procedure
Same day discharge		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective laparoscopic cholecystectomy
18 years old or over

Exclusion Criteria:

Emergency surgery
Under 18 year olds

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith J Roberts, MRCS	University Hospital Coventry and Warwickshire NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHCW NHS Trust		Coventry	Warwickshire	CV2 2DX	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21638181	Derived	Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surg Endosc. 2011 Nov;25(11):3698-705. doi: 10.1007/s00464-011-1757-3. Epub 2011 Jun 3.

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

ID	Term
D002045	Bupivacaine
D000077330	Saline Solution

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds