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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016797
Receipt No. R000019488
Scientific Title The Effect of Intraperitoneal Nebulization: Ropivacaine vs Lignocaine in Patients Undergoing Laparoscopic Cholecystectomy
Date of disclosure of the study information 2015/04/02
Last modified on 2015/03/14

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Basic information
Public title The Effect of Intraperitoneal Nebulization: Ropivacaine vs Lignocaine in Patients Undergoing Laparoscopic Cholecystectomy
Acronym The Effect of Intraperitoneal Nebulization: Ropivacaine vs Lignocaine in Patients Undergoing Laparoscopic Cholecystectomy
Scientific Title The Effect of Intraperitoneal Nebulization: Ropivacaine vs Lignocaine in Patients Undergoing Laparoscopic Cholecystectomy
Scientific Title:Acronym The Effect of Intraperitoneal Nebulization: Ropivacaine vs Lignocaine in Patients Undergoing Laparoscopic Cholecystectomy
Region
Asia(except Japan)

Condition
Condition The Effect of Intraperitoneal Nebulization: Ropivacaine vs Lignocaine in Patients Undergoing Laparoscopic Cholecystectomy.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 AIM: To compare of nebulization of intraperitoneal lignocaine and ropivacaine in relation to intraoperative haemodynamic & post-operative analgesic requirement. MATERIALS & METHODS: With approval from institutional ethics committee and informed written consent, 100 patients of ASA I-II, aged 20-60yrs, weighing 40-60kg, of either sex posted for surgery under GA were randomly allocated into two groups [L&R] of 50 each. All patients were pre-medicated with inj. Glycopyrolate, inj.Fentanyl, & inj.Midazolam. Pre-operative pulse, ECG, NIBP, Oxygen saturation were recorded. Following pre-oxygenation with 100% oxygen for 3min. Patients were induced & intubated with Propofol 2.5mg/kg , inj. Vecuronium 0.1mg/kg , ventilated with Nitrous oxide-Oxygen and intubated with proper size ET tube. Patients undergoing laparoscopic cholecystectomy were randomized to receive intraperitoneal nebulization of Ropivacaine 0.75% (3 Mg/kg) in group R and Lignocaine 4% (3mg/kg), in group L before surgical dissection. Nebulization was performed using the Aeroneb Pro device. Anaesthetic and surgical techniques were standardized. The degree of pain on deep breath or movement, analgesic consumption were collected in the post-anaesthesia care unit and at 6, 12, 18 & 24hrs after surgery. RESULTS. Data were tabulated analysed by using student Paired t-test & Chi-square test. p<0.05 considered to be significant. SUMMARY & CONCLUSION: Ropivacaine & Lignocaine nebulization before surgery reduced postoperative pain after laparoscopic cholecystectomy. So reduced analgesic requirements and allowed early mobility with an added advantage of significant intraoperative haemodynamic stability with Lignocaine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We conclude that intraperitoneal instillation of local an-aesthetic is an easy, cheap, and non-invasive method which provides better perioperative hemodynamic control along with good analgesia in the immediate postoperative period after laparoscopic surgery. This effect evaluated better with Lignocaine as compared to Ropivacaine. So Lignocaine can be used as a low cost alternative.

Key secondary outcomes The chief limitation of the study is poor visualization of the surgical field for the first few minutes which may delay the surgical procedure

Base
Study type

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Uncontrolled
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 Group L = Inj Lignocaine topical 4% 3mg/kg (maximum 4ml)

Interventions/Control_2 Group R = Inj Ropivacaine 0.75% 3mg/kg (maximum 4ml)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 100 patients of ASA I-II, age 20-60 yrs., wt. 40-60 kg scheduled for routine elective lap surgeries under GA
Key exclusion criteria 1.Pre-op pain other than biliary colic
2.Chronic pain t/t or anti-epileptic therapy
3.H/O alcohol or drug addiction
4.Severe hepatic or renal impairment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. Nibedita Sahoo
Organization MKCG Medical College & Hospital
Division name Department of Anaesthesiology
Zip code
Address Nibedita Sahoo, C/O Amulya CH. Sahoo, At. Mansing Bazar, post. Motiganj, Dist. Balasore, Odisha,Pin 756003, India
TEL 9861340962
Email nibeditasahoo2014@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Dr. Nibedita Sahoo
Organization MKCG Medical College & Hospital
Division name Department of Anaesthesiology
Zip code
Address Nibedita Sahoo, C/O Amulya CH. Sahoo, At. Mansing Bazar, post. Motiganj, Dist. Balasore, Odisha,Pin
TEL 9861340962
Homepage URL
Email nibeditasahoo2014@gmail.com

Sponsor
Institute Department of Anaesthesiology
MKCG Medical College
Institute
Department

Funding Source
Organization Department of Anaesthesiology
MKCG Medical College
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 no
Org. issuing International ID_1 no
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions MKCG Medical College & Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Intraperitoneal instillation of local an-aesthetic is an easy, cheap, and non-invasive method which provides better perioperative hemodynamic control along with good analgesia in the immediate postoperative period after laparoscopic surgery
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2014 Year 08 Month 31 Day
Date of closure to data entry
2014 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 09 Month 04 Day
Date analysis concluded
2014 Year 12 Month 18 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 14 Day
Last modified on
2015 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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