The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
Primary Purpose
Gynecologic Laparoscopic Surgery for Benign Adnexa Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
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
Sponsored by
About this trial
This is an interventional prevention trial for Gynecologic Laparoscopic Surgery for Benign Adnexa Disease
Eligibility Criteria
Inclusion Criteria:
- benign adnexa diseases which are scheduled for laparoscopic surgery
Exclusion Criteria:
- The procedure required conversion to a laparotomy, An operative time > 3 hours, Interpretation of pain was impossible due to serious adverse effects.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
instillation of normal saline 50ml under the diaphragm
the instillation of 0.5% bupivacaine under the diaphragm
CO2 removal by means of a pulmonary recruitment maneuver
the instillation of bupivacaine + CO2 removal by maneuver
Arm Description
Outcomes
Primary Outcome Measures
The degree of shoulder pain after gynecologic laparoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT01039441
First Posted
December 23, 2009
Last Updated
December 23, 2009
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01039441
Brief Title
The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
Official Title
The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Laparoscopic Surgery for Benign Adnexa Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
instillation of normal saline 50ml under the diaphragm
Arm Type
Placebo Comparator
Arm Title
the instillation of 0.5% bupivacaine under the diaphragm
Arm Type
Experimental
Arm Title
CO2 removal by means of a pulmonary recruitment maneuver
Arm Type
Experimental
Arm Title
the instillation of bupivacaine + CO2 removal by maneuver
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal instillation of bupivacaine
Intervention Description
A mixture of 50ml solution (20ml of 0.5% bupivacaine + 30ml normal saline) is instilled under the diaphragm.
Intervention Type
Procedure
Intervention Name(s)
CO2 removal by means of a pulmonary recruitment maneuver
Intervention Description
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 Type
Procedure
Intervention Name(s)
Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver
Intervention Type
Other
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
The degree of shoulder pain after gynecologic laparoscopy
Time Frame
During the first 24hours after surgery; 1,6, 12, 24hr
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
benign adnexa diseases which are scheduled for laparoscopic surgery
Exclusion Criteria:
The procedure required conversion to a laparotomy, An operative time > 3 hours, Interpretation of pain was impossible due to serious adverse effects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk Soo Bae, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32206659
Citation
Cho M, Kim CJ, Hahm TS, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS, Choi CH. Combination of a pulmonary recruitment maneuver and intraperitoneal bupivacaine for the reduction of postoperative shoulder pain in gynecologic laparoscopy: a randomized, controlled trial. Obstet Gynecol Sci. 2020 Mar;63(2):187-194. doi: 10.5468/ogs.2020.63.2.187. Epub 2020 Feb 20.
Results Reference
derived
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The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy
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