Pain Clinical Trial
Official title:
Randomized Controlled Study of Intraincisional Infiltration Versus Intraperitoneal Instillation of Standardized Dose of Ropivacaine 0.2% in Post-laparoscopic Cholecystectomy Pain
Verified date | August 2017 |
Source | Jawaharlal Nehru Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small space of intraincisional location as compared to similar amount of drug in large intraperitoneal space created an inadvertent bias in favor of patients receiving the drug intraincisionally so such patients naturally experienced less pain. The investigators decided to standardize the drug used at these two locations as 1ml/cm and conduct a new study comparing the effects of drugs in relieving pain when used at these two locations.
Status | Completed |
Enrollment | 353 |
Est. completion date | August 15, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 80 Years |
Eligibility |
Inclusion Criteria: - All patients in the age group of 15-80 years - Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA) physical status classification system only - Patients undergoing elective Laparoscopic Cholecystectomy - Patients having symptomatic cholelithiasis only - Patients operated by a single surgeon were included. Exclusion Criteria: - Patients with known allergic reactions to local anesthetics - Cases that were converted to open cholecystectomy - Patients with major intra-operative complications - Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder, having history of chronic pain or those taking frequent analgesics or opioids pre-operatively - Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic function, and sensitivity to NSAIDs or opioids. - Patients in whom gall bladder (GB) stones are found incidentally on ultrasonography (USG) (asymptomatic cholelithiasis) - Patients suffering from severe chronic medical diseases and morbid obesity - Patients unable to comprehend instructions or having communication problems were excluded from the study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Jawaharlal Nehru Medical College |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain | To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief. | 36 months | |
Secondary | Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy | To identify the component of pain (visceral versus incisional component) that is dominant after laparoscopic cholecystectomy; and after how much interval of time it assumes importance? | 36 months | |
Secondary | Laparoscopic cholecystectomy as day-case using ropivacaine only | To strive for making laparoscopic cholecystectomy a truly day case procedure in the public setup of developing countries like India by using this cheap local anaesthetic alone | 36 months | |
Secondary | Changing trends in epidemiology of cholelithiasis | To check for any changing trends in epidemiology of cholelithiasis in North India | 36 months |
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