Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

Israel Healthcare Foundation

Status and phase: Completed; Phase 3

Conditions: Laparoscopic Surgical Procedures

Treatments: Drug: ropivacaine; Device: Aeroneb Pro Nezulizer, Aerogen, Ireland

Study type: Interventional

Funder types: Other

Identifiers

NCT00433316

HT 3758

CMC064113CTIL

Details and patient eligibility

About

In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
• The patient is not participating in other medical study at present or in the last 30 days.
• The patient signed on an informed consent.
• Age 18 years and above.
• ASA (American Society of Anesthesiologists) physical status grade 1- 2.

Exclusion criteria

• Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
• The patient is participating in other medical experiment at present or in the last 30 days.
• Acute Pelvic Inflammatory Disease.
• Coumadin or Aspirin treatment.
• ASA physical status grade 3-4.
• Age < 18 years.
• Significant arrythmias
• Analgesic treatment for chronic pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

study

Experimental group

Description:

Receiving 10ml of 1% ropivacaine

Treatment:

Drug: ropivacaine

Control

Placebo Comparator group

Description:

Receiving 10ml of saline

Treatment:

Device: Aeroneb Pro Nezulizer, Aerogen, Ireland