Marcaine Use in Laparoscopic Gynecological Surgery

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Post-operative Pain

Treatments: Drug: Marcaine 0.25%.; Drug: Marcaine- 0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT01861665

1004010977

Details and patient eligibility

About

The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.

Full description

Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Ages 18-50

  • BMI 20-35
  • Gynecologic ambulatory cases only
  • Total of 3 incisions, with left and right incisions both being 5mm-10mm in size
  • Not taking pain medications prior to surgery
  • Length of surgery up to 3 hours
  • PACU stay up to 6 hours
  • Willing and able to sign informed consent

Exclusion criteria

• • Age or BMI out of range

  • Surgery longer than 3 hours or PACU stay longer than 6 hours
  • patients with chronic pelvic pain
  • Oncologic cases
  • Pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

27 participants in 2 patient groups

Marcaine administered pre-incision.

Active Comparator group

Description:

Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.

Treatment:

Drug: Marcaine- 0.25%

Marcaine administered post-incision

Active Comparator group

Description:

Marcaine 0.25% administered post-incision, total amount 5cc per incision.

Treatment:

Drug: Marcaine 0.25%.