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

Stony Brook University

Status: Unknown

Conditions: Post Operative Pain

Treatments: Drug: Saline will be in injected into the port site prior to closure; Drug: 0.25% bupivicaine will be injected into the port site prior to closure; Drug: 0.25% bupivicaine will be injected at the study port site prior to incision; Drug: Saline will be injected at the study port site prior to incision

Study type: Interventional

Funder types: Other

Identifiers

NCT01452633

241577-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients undergoing laparoscopic surgery

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Preincision Placebo

Placebo Comparator group

Description:

This group of patients will receive saline injection at study port site before incision

Treatment:

Drug: Saline will be injected at the study port site prior to incision

Preincision Marcaine

Active Comparator group

Description:

This group will receive marcaine injection at the study port site prior to incision

Treatment:

Drug: 0.25% bupivicaine will be injected at the study port site prior to incision

Postincision Placebo

Placebo Comparator group

Description:

This group of patients will receive preincisional marcaine and then saline injection at study port site prior to closure

Treatment:

Drug: Saline will be in injected into the port site prior to closure

Drug: 0.25% bupivicaine will be injected at the study port site prior to incision

Postincision marcaine

Active Comparator group

Description:

This group will receive preincisional marcaine and then marcaine injection at study port site prior to closure

Treatment:

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