Gynecologic Laparoscopic Surgery for Benign Adnexa Disease Clinical Trial
Official title:
The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention