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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain, Postoperative
• Interventions: Drug: Nebulised Bupivacaine intraperitoneally; Drug: Normal Saline; Drug: Injected Bupivacaine intraperitoneally; Other: No Intraperitoneal Therapeutics
• Enrollment: 80

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Control	IP Aerosolized Normal Saline	Nebulised Bupivacaine Intraperitoneally	Injected Bupivacaine Intraperitoneally
Arm/Group Description	No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given	Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline	Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)	Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
Period Title: Overall Study
Started	20	20	20	20
Completed	20	20	20	20
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		Control	IP Aerosolized Normal Saline	Nebulised Bupivacaine Intraperitoneally	Injected Bupivacaine Intraperitoneally	Total
Arm/Group Description		No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given	Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline	Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)	Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity	Total of all reporting groups
Overall Number of Baseline Participants		20	20	20	20	80
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	20 participants	20 participants	20 participants	20 participants	80 participants
		47.65; (25 to 75)	47.65; (26 to 74)	51.60; (25 to 83)	48.70; (34 to 79)	49; (25 to 83)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	20 participants	20 participants	80 participants
	Female	16 80.0%	18 90.0%	17 85.0%	18 90.0%	69 86.3%
	Male	4 20.0%	2 10.0%	3 15.0%	2 10.0%	11 13.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United Kingdom	Number Analyzed	20 participants	20 participants	20 participants	20 participants	80 participants
		20	20	20	20	80

Outcome Measures

1. Primary Outcome

Title	Reduction in Postoperative Pain
Description	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.
Time Frame	0 hours, 6 hours, 12 hours, 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	IP Aerosolized Normal Saline	Nebulised Bupivacaine Intraperitoneally	Injected Bupivacaine Intraperitoneally
Arm/Group Description:	No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given	Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline	Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)	Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
Overall Number of Participants Analyzed	20	20	20	20
Mean (Full Range); Unit of Measure: units on a scale
Pain in Recovery (0 Hours)	9.2; (3 to 10)	10; (10 to 10)	3.3; (1 to 10)	9.3; (5 to 10)
Pain at 6 hours	8.2; (5 to 10)	8.1; (4 to 10)	0.7; (0 to 3)	7.2; (4 to 10)
Pain at 12 hours	7.9; (3 to 10)	8; (4 to 10)	0.6; (0 to 3)	6.7; (4 to 10)
Pain at 24 hours	6.1; (4 to 10)	6.2; (2 to 10)	0.5; (0 to 3)	5.6; (3 to 8)

2. Secondary Outcome

Title	Number of Vomiting / Nausea Episodes
Description	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.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	IP Aerosolized Normal Saline	Nebulised Bupivacaine Intraperitoneally	Injected Bupivacaine Intraperitoneally
Arm/Group Description:	No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given	Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline	Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)	Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
Overall Number of Participants Analyzed	20	20	20	20
Mean (Full Range); Unit of Measure: Number of vomitting / Nausea episodes
	7.1; (5 to 9)	7.1; (3 to 8)	2; (0 to 4)	6.8; (2 to 9)

3. Secondary Outcome

Title	Hours Needed for Safe Mobilization
Description	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.
Time Frame	24 Hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	IP Aerosolized Normal Saline	Nebulised Bupivacaine Intraperitoneally	Injected Bupivacaine Intraperitoneally
Arm/Group Description:	No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given	Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline	Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)	Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
Overall Number of Participants Analyzed	20	20	20	20
Mean (Full Range); Unit of Measure: Hours needed for safe mobilization
	6.7; (4 to 10)	6.5; (4 to 11)	3; (2 to 4)	6.4; (3 to 9)

4. Secondary Outcome

Title	Postoperative Morphine Use
Description	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
Time Frame	24 Hoiurs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	IP Aerosolized Normal Saline	Nebulised Bupivacaine Intraperitoneally	Injected Bupivacaine Intraperitoneally
Arm/Group Description:	No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given	Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline	Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)	Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
Overall Number of Participants Analyzed	20	20	20	20
Mean (Full Range); Unit of Measure: mg
	25.9; (10 to 45)	26.3; (10 to 50)	1; (0 to 10)	16.7; (8 to 30)

Adverse Events

Time Frame	24 Hours
Adverse Event Reporting Description	Nausea and Vomiting
Arm/Group Title	Control		IP Aerosolized Normal Saline		Nebulised Bupivacaine Intraperitoneally		Injected Bupivacaine Intraperitoneally
Arm/Group Description	No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given		Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline		Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)		Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
All-Cause Mortality
	Control		IP Aerosolized Normal Saline		Nebulised Bupivacaine Intraperitoneally		Injected Bupivacaine Intraperitoneally
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	Control		IP Aerosolized Normal Saline		Nebulised Bupivacaine Intraperitoneally		Injected Bupivacaine Intraperitoneally
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0.00%)		0/20 (0.00%)		0/20 (0.00%)		0/20 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Control		IP Aerosolized Normal Saline		Nebulised Bupivacaine Intraperitoneally		Injected Bupivacaine Intraperitoneally
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/20 (25.00%)		5/20 (25.00%)		1/20 (5.00%)		5/20 (25.00%)
Gastrointestinal disorders
Nausea and Vomiting † 1 [1]	5/20 (25.00%)	9	5/20 (25.00%)	8	1/20 (5.00%)	4	5/20 (25.00%)	9
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, Patient Chart; [1] Number of Nausea / vomiting episodes recorded in patient's chart

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Nawar Alkhamesi
• Organization: Imperial College London
• Phone: 442033121110
• EMail: n.alkhamesi@imperial.ac.uk

Publications of Results:

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.

• Responsible Party: Nawar Alkhamesi, 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 Submitted: September 12, 2005
• First Posted: September 16, 2005
• Results First Submitted: June 9, 2015
• Results First Posted: September 15, 2015
• Last Update Posted: September 15, 2015