Clinical Trial of the Use of Intraperitoneal Local Anaesthetic

• 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: Imperial College London
• Information provided by (Responsible Party): Nawar Alkhamesi, Imperial College London

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 16, 2005
• Results First Submitted Date: June 9, 2015
• Results First Posted Date: September 15, 2015
• Last Update Posted Date: September 15, 2015
• Study Start Date: October 2004
• Actual Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 12, 2015)

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.

• Original Primary Outcome Measures (submitted: September 12, 2005): Reduction in postoperative pain and hospitalisation

Current Secondary Outcome Measures (submitted: August 12, 2015)

• 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.
• 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.
• 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

• Original Secondary Outcome Measures (submitted: September 12, 2005): Reduction in cost
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial of the Use of Intraperitoneal Local Anaesthetic
• Official Title: Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic
• 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.

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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain, Postoperative

Intervention

• Drug: Nebulised Bupivacaine intraperitoneally
  Nebulised Marcaine (Bupivacaine)
  Other Name: Marcaine
• Drug: Normal Saline
  Nebulised Normal Saline
  Other Name: 0.9 % Normal Saline
• Drug: Injected Bupivacaine intraperitoneally
  Injected Marcaine directly into the peritoneal cavity
  Other Name: Marcaine
• Other: No Intraperitoneal Therapeutics
  No Intraperitoneal Therapeutics given

Study Arms

• Sham Comparator: Control
  No intraperitoneal therapeutics (No nebulised Bupivacaine)
  Intervention: Other: No Intraperitoneal Therapeutics
• Placebo Comparator: IP Aerosolized Normal Saline
  Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
  Intervention: Drug: Normal Saline
• Experimental: Nebulised Bupivacaine intraperitoneally
  Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
  Intervention: Drug: Nebulised Bupivacaine intraperitoneally
• Active Comparator: Injected Bupivacaine intraperitoneally
  Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
  Intervention: Drug: Injected Bupivacaine intraperitoneally

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2005): 80
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2005
• Actual Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nawar Alkhamesi, Imperial College London
• Original Responsible Party: Not Provided
• Current Study Sponsor: Imperial College London
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nawar A Alkhamesi, MD, PhD; Imperial College London

• PRS Account: Imperial College London
• Verification Date: August 2015