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Completed

NCT Number: NCT00180687

Clinical Trial of the Use of Intraperitoneal Local Anaesthetic

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Mary's Hospital

London, W2 1NY, United Kingdom

About this study

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:

  • Control group
  • Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Nebulised Bupivacaine intraperitoneally

Drug

Nebulised Marcaine (Bupivacaine)

Other names: Marcaine

normal saline

Drug

Nebulised Normal Saline

Other names: 0.9 % Normal Saline

Injected Bupivacaine intraperitoneally

Drug

Injected Marcaine directly into the peritoneal cavity

Other names: Marcaine

No Intraperitoneal Therapeutics

Other

No Intraperitoneal Therapeutics given

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Sep 15, 2015

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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