Health Condition 1: 3- Administration
Conditions
Interventions
Intervention1: Ropivacaine Readyfusor 2mg/ml: as a continuous surgical site infusion for the Treatment of Post-Surgical Pain in lower abdominal laparotomy
Control Intervention1: Ropivacaine Balloon Pu
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant or participantââ?¬•s legally acceptable representative is willing and able to give informed consent 2. Subjects of either gender with age 18 to 65 years (both inclusive) scheduled for lower abdominal surgery 3. Patient scheduled to undergo lower abdominal laparotomy surgery with requirement of hospitalization for at least 3 days 4. The length of surgical site incision should be around 15Ã?±3cms 5. Able and willing to comply with all study requirements 6. Subject doesnââ?¬•t suffer from any significant co-morbidity which in the opinion of the investigator renders the patient unfit for the studyââ?¬• American Society of Anesthesiologists [ASA] I-II
Exclusion criteria
Exclusion criteria: 1. History of allergy to study related drug, which would preclude all the possible combinations, capable of providing usual care multimodal analgesia: other local anesthetics, morphine, oxycodone, fentanyl, paracetamol 2. Body weight 3. Clinically significant illness or surgery within 1 week prior to screening visit (including flu, flu like symptoms, diarrhea, vomiting, ongoing sepsis/bacterial infections) 4. Any skin lesion/abnormality at site of catheterization 5. Chronic pain, with or without long-term regular analgesic usage 6. History of substance abuse 7. Pregnant or breast-feeding females 8. Participants not able to discontinue the prohibited medications listed in the protocol within the allotted time before surgery and throughout their duration of participation in the study ââ?¬Â¢ Monoamine oxidase inhibitors within the past 30 days ââ?¬Â¢ Anticonvulsants, tricyclic antidepressants (TCAs), neuroleptics, serotonin-norepinephrine reuptake inhibitors (SNRIs), as well as selective serotonin reuptake inhibitors (SSRIs; unless SSRIs have been prescribed for depression and/or anxiety and patients have been on a stable dose for at least 30 days prior to the screening visit) ââ?¬Â¢ Corticosteroids: Oral and injectable corticosteroids must be discontinued 3 months prior to surgery; nasal, inhaled and topical corticosteroids will be allowed 9. Patients who have participated in any clinical trial within past 12 weeks 10. Chronic, high-dose opioid use (greater than 20 mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use > 4 weeks) 11. Concurrent painful physical conditions that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the lower abdominal surgery of this study as pain from these conditions may confound postsurgical assessments 12. Any opioid medications, NSAIDs, or aspirin (except for low-dose aspirin used for cardioprotection) within 24 hours of study drug administration 13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participantââ?¬•s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving analgesic success measured through visual analogue score of ââ?°Â¤ 3 at 24 hours after the start of Ropivacaine infusion between both treatment armsTimepoint: at 24 hours post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Pain intensity scores using visual analogue score (VAS; 0-10 mm) on 0, 6, 12, 24, 36 and 48 hours post-surgery 2 Difference in time required from unpacking the unit from its outer box to infusion of both therapies 3 Difference in number of doses of rescue medication consumed over 48 hrs of infusion period 4 Subject satisfaction with postsurgical pain control at 48 hours using a 5-point Likert scale 6 Investigatorââ?¬â?¢s satisfaction for analgesic therapy using a 5-point Likert scaleTimepoint: 0, 6, 12, 24, 36 and 48 hours post-surgery | — |
Countries
India
Contacts
Public ContactAbhijit Vaidya
Cipla Ltd
Outcome results
None listed