Advertisement

Topics

The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy

2014-08-27 03:17:00 | BioPortfolio

Summary

This prospective, randomized controlled trial was designed to compare the efficacy of a simple maneuver using lower airway pressure (30 cm H2O) and intraperitoneal instillation of bupivacaine, alone or in combination, to reduce shoulder pain after gynecologic laparoscopy.

Patient aged 15-65 years, scheduled for laparoscopic surgery for benign adnexa disease will be eligible for the study. Patients will be excluded from analysis if the procedure requires conversion to a laparotomy, an operative time > 3 hours, or interpretation of pain is impossible due to serious adverse effects

240 patients will be randomly assigned to one of four groups Upon completion of surgery, the patient is placed in the Trendelenburg position (30 degrees), and one of four procedures is followed. For group A (control), 50 ml of normal saline is instilled under the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group B, a mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm and CO2 is removed by manual deflation of the abdominal cavity through the cannula; For group C, 50 ml of normal saline is instilled under diaphragm and CO2 was removed by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung with a maximum pressure of 30 cm H2O. The anesthesiologist holds the fifth positive pressure inflation for approximately 5 seconds. During these maneuvers, the surgeon will be instructed to ensure that the trocar sleeve valve is fully open to allow the CO2 gas to escape. For group D, patients receive an instillation of a mixture of 50ml solution in combination with the clinical maneuver.

Patients will be given a questionnaire with the pain question represented as a visual analog scale (VAS) preoperatively. Patients will be asked to fill out the questionnaires during the first 24 hours after surgery to determine the frequency and severity of their shoulder pain. All patients are instructed to record the pain scores regarding their shoulder pain only. The degree of postoperative shoulder pain will be assessed using VAS at 1, 6, 12, and 24 hours postoperatively. The VAS, with scores ranging from 0 (no pain) to 10 (excruciating pain), is constructed without numeration, thus allowing patients to mark a point along the scale that best represented their pain at that time.

In addition, the following parameters are recorded on the case report form by the investigators: operative time, blood loss, the length of hospital stay, analgesic use, and incidence of postoperative events.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Gynecologic Laparoscopic Surgery for Benign Adnexa Disease

Intervention

Intraperitoneal instillation of bupivacaine, CO2 removal by means of a pulmonary recruitment maneuver, Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver, normal saline

Location

Samsung Medical Center
Seoul
Korea, Republic of
135-710

Status

Completed

Source

Samsung Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:00-0400

Clinical Trials [2055 Associated Clinical Trials listed on BioPortfolio]

Effective Maneuver for Post-laparoscopic Shoulder Pain

The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for r...

Alveolar Recruitment Maneuver During Pneumoperitoneum

Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study for compa...

The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children

We investigate whether the atelectasis can be prevented in the recovery room when recruitment maneuver is performed after anesthetic induction in children. In addition, we also investigate...

Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese

Morbid obese patients present changes in respiratory physiology caused by weight overload. Intraoperative atelectasis is a pulmonary complication that affects not only gas exchange but als...

The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery

Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery

Medical and Biotech [MESH] Definitions

Tests for measuring loudness recruitment.

Removal of an autonomic or sensory ganglion by any means.

The production of adhesions between the parietal and visceral pleura. The procedure is used in the treatment of bronchopleural fistulas, malignant pleural effusions, and pneumothorax and often involves instillation of chemicals or other agents into the pleural space causing, in effect, a pleuritis that seals the air leak. (From Fishman, Pulmonary Diseases, 2d ed, p2233 & Dorland, 27th ed)

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

The removal of secretions, gas or fluid from hollow or tubular organs or cavities by means of a tube and a device that acts on negative pressure.

More From BioPortfolio on "The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pain
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...


Searches Linking to this Trial