UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016797 |
|---|---|
| Receipt number | 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 02:11:27 |
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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
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
nibeditasahoo2014@gmail.com
Sponsor or person
Institute
Department of Anaesthesiology
MKCG Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019488
