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

December 23, 2009 updated by: Samsung Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The degree of shoulder pain after gynecologic laparoscopy
Time Frame: During the first 24hours after surgery; 1,6, 12, 24hr
During the first 24hours after surgery; 1,6, 12, 24hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

December 25, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-07-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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