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Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy

Effect of Preincisional Local Analgesia on Post-Operative Pain in 10-12mm Lateral Port Sites

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01452633
Enrollment
100
Registered
2011-10-17
Start date
2011-11-30
Completion date
2014-05-31
Last updated
2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

pain, laparoscopy, reduction

Brief summary

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.

Detailed description

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.

Interventions

DRUG0.25% bupivicaine will be injected at the study port site prior to incision

Injection will precede the incision

DRUGSaline will be injected at the study port site prior to incision

Injection will precede incision

DRUGSaline will be in injected into the port site prior to closure

Saline will be injected into the port site prior to the closure without any preincisional intervention

DRUG0.25% bupivicaine will be injected into the port site prior to closure

0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* patients undergoing laparoscopic surgery

Exclusion criteria

* Cardiovascular instability * malignancies * pulmonary conditions incompatible with laparoscopic surgery

Design outcomes

Primary

MeasureTime frameDescription
Reduction in post-operative pain at large lateral port sites4 and 24 hours after surgeryvisual analog scoring of post-operative pain in a control and a treatment group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026