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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01039441
First received: December 23, 2009
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Local Anesthesia and Simple Maneuver on Shoulder Pain After Gynecologic Laparoscopy

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The degree of shoulder pain after gynecologic laparoscopy [ Time Frame: During the first 24hours after surgery; 1,6, 12, 24hr ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01039441

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Duk Soo Bae, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Duk Soo Bae/Chairman of Dept. of Ob. & Gyn, The department of obstetrics and gynecology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01039441     History of Changes
Other Study ID Numbers: 2008-07-071
Study First Received: December 23, 2009
Last Updated: December 23, 2009
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014