A Phase 4 interventional study of 0.2% ropivacaine in Ropivacaine, Laparoscopic Cholecystectomy and Pain, sponsored by Jawaharlal Nehru Medical College. Completed. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Jawaharlal Nehru Medical College · Phase 4, Interventional, and Treatment
Among 77 studies testing ropivacaine in Pain — 3 open to participants now, 3 under way, 1 of them phase 3. Ropivacaine · Pain.
Among the 77 studies testing ropivacaine in Pain, this one is the 2nd largest by enrollment, is one of 9 that started in 2014, is one of 34 in phase 4, and was the 56th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 353 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →3 of the 77 studies testing ropivacaine in Pain are open now, in 3 countries. Each count lists the studies.
Ropivacaine: first FDA approval 1996 (NAROPIN). What it is approved for, and how studies give it, is on its page →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 15 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →77 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 9 started in 2014.
Median enrollment 60 across the 77 interventional studies. Of the 55 that completed or were terminated, 17 (31%) have results posted.
1 of 77 have an industry lead sponsor. The 10 most frequent:
Jawaharlal Nehru Medical College is the lead sponsor of 5 studies on the registry; none are open to participants now.
Jawaharlal Nehru Medical College has 1 study filed under Pain — fewer than ten, so there is no comparison to draw.
1 of the studies testing ropivacaine in Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03796572University of California, Los AngelesRegional Blocks for Lateral Condyle Fractures | 2027-01-07 |
Among the 77 studies testing ropivacaine in Pain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Aims \& Objectives: To conduct a randomized, triple-blind, placebo-controlled study by standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain relief.
Materials \& Methods: American Society of Anesthesiologists (ASA) physical status I or II patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon. Anesthetic and surgical techniques were standardized. Patients were randomized using envelope method into 3 groups according to location of drug use. Triple blinding was ensured and envelopes were opened only at the completion of study. All patients received \~23 ml of solution, of which 20 ml was given intraperitoneally [1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and \~3 ml intraincisionally (1 ml/cm of length of incision). Controls (n=86) received \~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally) while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1 ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure. All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly postoperatively. 5 different pain scales were used for assessment of overall pain. Pain scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were also recorded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received 1 ml/cm normal saline (23 ml) both at intraperitoneal (=20 ml) as well as intraincisional (=3 ml) location.
Received 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length)
Drug: 0.2% ropivacaine
Received 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length)
Drug: 0.2% ropivacaine
Intraperitoneal instillation versus intraincisional infiltration
Also known as: Ropin, Naropin
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.
Time frame: 36 months
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?
Time frame: 36 months
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
Time frame: 36 months
Changing trends in epidemiology of cholelithiasis
To check for any changing trends in epidemiology of cholelithiasis in North India
Time frame: 36 months
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Data of those patients will be shared patients who will give consent for the same.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Jawaharlal Nehru Medical College