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

Phase 2

Completed

• Conditions: Gynecologic Laparoscopic Surgery for Benign Adnexa Disease
• Interventions: Other: normal saline; 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

• Registration Number: NCT01039441
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-12
• Primary Completion: 2009-03
• Study Completion: 2009-07
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-23
• Last Update Submitted: 2009-12-23
• Study First Posted: 2009-12-25
• Last Update Posted: 2009-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 291

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
instillation of normal saline 50ml under the diaphragm	normal saline	-
the instillation of 0.5% bupivacaine under the diaphragm	Intraperitoneal instillation of bupivacaine	-
CO2 removal by means of a pulmonary recruitment maneuver	CO2 removal by means of a pulmonary recruitment maneuver	-
the instillation of bupivacaine + CO2 removal by maneuver	Intraperitoneal instillation of bupivacaine +CO2 removal by means of a pulmonary recruitment maneuver	-

Primary Outcome Measures

Name	Time	Method
The degree of shoulder pain after gynecologic laparoscopy	During the first 24hours after surgery; 1,6, 12, 24hr

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of