An interventional study of 0.25% bupivicaine will be injected at the study port site prior to incision and Saline will be injected at the study port site prior to incision in Post Operative Pain, sponsored by Stony Brook University. Status unknown at 1 site in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-10.
Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment
This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.
The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 100 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Stony Brook University is the lead sponsor of 197 studies on the registry; 37 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
This group of patients will receive saline injection at study port site before incision
Drug: Saline will be injected at the study port site prior to incision
This group will receive marcaine injection at the study port site prior to incision
Drug: 0.25% bupivicaine will be injected at the study port site prior to incision
This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure
Drug: 0.25% bupivicaine will be injected at the study port site prior to incision · Drug: Saline will be in injected into the port site prior to closure
This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure
Drug: 0.25% bupivicaine will be injected at the study port site prior to incision · Drug: 0.25% bupivicaine will be injected into the port site prior to closure
Injection will precede the incision
Also known as: marcaine
Injection will precede incision
Also known as: normal saline
Saline will be injected into the port site prior to the closure without any preincisional intervention
0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention
Also known as: marcaine
Reduction in post-operative pain at large lateral port sites
visual analog scoring of post-operative pain in a control and a treatment group
Time frame: 4 and 24 hours after surgery
The record gives a start of Nov 2011, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine