The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
Condition: Gynecologic Laparoscopic Surgery for Benign Adnexa Disease
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): 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
Intervention type(s): Procedure; Procedure; Procedure; Other
Intervention description(s): A mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm.; CO2 is removed by means of a pulmonary recruitment maneuver consisting of five manual inflations of the lung with a maximum pressure of 30 cm H2O
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention