The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01039441|
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : December 25, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Laparoscopic Surgery for Benign Adnexa Disease||Procedure: Intraperitoneal instillation of bupivacaine Procedure: CO2 removal by means of a pulmonary recruitment maneuver Procedure: Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver Other: normal saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||291 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||July 2009|
|Placebo Comparator: instillation of normal saline 50ml under the diaphragm||
Other: normal saline
|Experimental: the instillation of 0.5% bupivacaine under the diaphragm||
Procedure: Intraperitoneal instillation of bupivacaine
A mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm.
|Experimental: CO2 removal by means of a pulmonary recruitment maneuver||
Procedure: CO2 removal by means of a pulmonary recruitment maneuver
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
|Experimental: the instillation of bupivacaine + CO2 removal by maneuver||
Procedure: Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver
- The degree of shoulder pain after gynecologic laparoscopy [ Time Frame: During the first 24hours after surgery; 1,6, 12, 24hr ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039441
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Duk Soo Bae, MD, PhD||Samsung Medical Center|