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Clinical Trial of the Use of Intraperitoneal Local Anaesthetic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00180687
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Nawar Alkhamesi, Imperial College London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Nebulised Bupivacaine intraperitoneally Drug: Normal Saline Drug: Injected Bupivacaine intraperitoneally Other: No Intraperitoneal Therapeutics Phase 3

Detailed Description:

Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly reduces postoperative pain particularly referred to the shoulder tip. Realistically, however, if attention is paid to expelling the residual gas at the end of the procedure this complication is rarely problematic. Operative site pain however is more difficult to manage. In limited gynaecological procedures it has been shown that local installation of local anaesthetic decreased the analgesic requirement of patients post operatively. These observations would not be as transferable to more extensive colorectal or solid organ surgery as the amount of local anaesthesia required would be toxic to the patient. Use of the nebuliser, however maybe able to alleviate pain by efficiently using the dosage required.

This is a prospective randomised double blind trial. Sixty patients will be allocated randomly between three groups, 20 patients in each group:

  1. Control group
  2. Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg)
  3. Nebulised intraperitoneal normal saline Ward staff will be blinded to which group the patients are in. All patients undergoing laparoscopic cholecystectomy who have given written, informed consent are eligible for inclusion. Patients with local anaesthetics allergy and patients whom pain evaluation is considered unreliable due to chronic opiate use or neurological diseases are excluded.

No pre-medication is to be given and a standardised anaesthetic technique is to be employed for all patients.

Standard 4 ports technique for laparoscopic cholecystectomy will be used with intraperitoneal pressure between 12-14 mmHg. This will be achieved using CO2 as the insufflation gas.

The local anaesthetic (approximately 10mls) will be delivered via a fine sterile catheter that will be inserted via the epigastric port under direct vision at the end of the procedure. Afterward the pneumoperitoneum will be deflated and the wound will be closed and subcutaneous local anaesthetic will be injected in and around the wounds.

Postoperatively, all the patients will have PCA as the main analgesia supported by NSAIDs unless contraindicated. Patients will eat and drink as desired and drips will be taken as soon as it is safe to do so.

Postoperative pain scoring will be stared in recovery and continue on the wards using the visual analogue scale.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic
Study Start Date : October 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Control
No intraperitoneal therapeutics (No nebulised Bupivacaine)
 Other: No Intraperitoneal Therapeutics
No Intraperitoneal Therapeutics given
Placebo Comparator: IP Aerosolized Normal Saline
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
 Drug: Normal Saline
Nebulised Normal Saline
Other Name: 0.9 % Normal Saline
Experimental: Nebulised Bupivacaine intraperitoneally
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
 Drug: Nebulised Bupivacaine intraperitoneally
Nebulised Marcaine (Bupivacaine)
Other Name: Marcaine
Active Comparator: Injected Bupivacaine intraperitoneally
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
 Drug: Injected Bupivacaine intraperitoneally
Injected Marcaine directly into the peritoneal cavity
Other Name: Marcaine


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Postoperative Pain [ Time Frame: 0 hours, 6 hours, 12 hours, 24 hours ]
    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.


Secondary Outcome Measures :
  1. Number of Vomiting / Nausea Episodes [ Time Frame: 24 hours ]
    Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.

  2. Hours Needed for Safe Mobilization [ Time Frame: 24 Hours ]
    Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.

  3. Postoperative Morphine Use [ Time Frame: 24 Hoiurs ]
    The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All they patients undergoing laparoscopic cholecystectomy will be included.

Exclusion Criteria:

  • Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180687


Locations
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United Kingdom
St. Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Nawar A Alkhamesi, MD, PhD Imperial College London
More Information
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Publications of Results:

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Responsible Party: Nawar Alkhamesi, Clinical Research Fellow, Imperial College London
ClinicalTrials.gov Identifier: NCT00180687    
Other Study ID Numbers: 02.CD/218E
Dr. David Peck ( Other Identifier: Imperial College London )
Prof. Sir Ara Darzi ( Other Identifier: Imperial College London )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: September 15, 2015
Last Update Posted: September 15, 2015
Last Verified: August 2015
Keywords provided by Nawar Alkhamesi, Imperial College London:
Pain
Nebulisation
Cholecystectomy
 Laparoscopic
Bupivacaine
Local Anaesthetic
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Coal Tar
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Keratolytic Agents
Dermatologic Agents