NCT00180687

Brief Summary

Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
10 years until next milestone

Results Posted

Study results publicly available

September 15, 2015

Completed
Last Updated

September 15, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

September 12, 2005

Results QC Date

June 9, 2015

Last Update Submit

August 12, 2015

Conditions

Pain, Postoperative

Keywords

PainNebulisationCholecystectomyLaparoscopicBupivacaineLocal Anaesthetic

Outcome Measures

Primary Outcomes (1)

  • Reduction in Postoperative Pain

    Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.

    0 hours, 6 hours, 12 hours, 24 hours

Secondary Outcomes (3)

  • Number of Vomiting / Nausea Episodes

    24 hours

  • Hours Needed for Safe Mobilization

    24 Hours

  • Postoperative Morphine Use

    24 Hoiurs

Study Arms (4)

Control

SHAM COMPARATOR

No intraperitoneal therapeutics (No nebulised Bupivacaine)

Other: No Intraperitoneal Therapeutics

IP Aerosolized Normal Saline

PLACEBO COMPARATOR

Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)

Drug: Normal Saline

Nebulised Bupivacaine intraperitoneally

EXPERIMENTAL

Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)

Drug: Nebulised Bupivacaine intraperitoneally

Injected Bupivacaine intraperitoneally

ACTIVE COMPARATOR

Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)

Drug: Injected Bupivacaine intraperitoneally

Interventions

Nebulised Bupivacaine intraperitoneallyDRUG

Nebulised Marcaine (Bupivacaine)

Also known as: Marcaine
Nebulised Bupivacaine intraperitoneally
Normal SalineDRUG

Nebulised Normal Saline

Also known as: 0.9 % Normal Saline
IP Aerosolized Normal Saline
Injected Bupivacaine intraperitoneallyDRUG

Injected Marcaine directly into the peritoneal cavity

Also known as: Marcaine
Injected Bupivacaine intraperitoneally
No Intraperitoneal TherapeuticsOTHER

No Intraperitoneal Therapeutics given

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All they patients undergoing laparoscopic cholecystectomy will be included.

You may not qualify if:

  • Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.

    PMID: 17180268RESULT

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Nawar Alkhamesi
Organization
Imperial College London
n.alkhamesi@imperial.ac.uk
442033121110

Study Officials

  • Nawar A Alkhamesi, MD, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

September 15, 2015

Results First Posted

September 15, 2015

Record last verified: 2015-08

Locations

GB(1)