Decreasing Upper and Shoulder Pain After Laparoscopic Surgery - Full Text View

Purpose

Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

Condition	Intervention	Phase
Shoulder Pain Nausea	Procedure: Pulmonary recruitment maneuver Procedure: Intraperitoneal normal saline infusion Procedure: combined group Procedure: Control group	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Further study details as provided by Taipei Veterans General Hospital,Taiwan:

Primary Outcome Measures:

The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery [ Time Frame: The first 48 hours after the surgery ] [ Designated as safety issue: Yes ]
The investigators will follow the patient in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder and upper abdominal pain after laparoscopic surgery.

Secondary Outcome Measures:

nausea or abdominal fullness after laparoscopic surgery [ Time Frame: The first 38 hours after the surgery ] [ Designated as safety issue: Yes ]
postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded.

Estimated Enrollment:	200
Study Start Date:	February 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pulmonary recruitment maneuver A pulmonary recruitment maneuver consisting five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.	Procedure: Pulmonary recruitment maneuver A pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds. Other Name: pulmonary recruitment maneuver
Experimental: Intraperitoneal normal saline infusion The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc we will leave the fluid in the abdominal cavity.	Procedure: Intraperitoneal normal saline infusion The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. We will leave the fluid in the abdominal cavity Other Name: intraperitoneal normal saline infusion
Experimental: combined group The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH20. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.	Procedure: combined group The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure oof 60 cmH2O. Other Name: combined group
Placebo Comparator: Control group Co2 was removed by passive exsufflation through the port site	Procedure: Control group Co2 was removed by passive exsufflation through the port site. Other Name: control group

Detailed Description:

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients receive benign gynecological laparoscopic surgery
American Society of Anesthesiologists(ASA) physical status of patient classification I-II.

Exclusion Criteria:

The procedure will be required to conversion to laparotomy
Any cardio-vascular diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433874

Contacts

Contact: Yi-Jen Chen, M.D., Ph D.

886-2-2875-7566

chenyj@vghtpe.gov.tw

Locations

Taiwan
Taipei Veterans General Hospital	Recruiting
Taipei, Taiwan, 112
Contact: Yi-Jen Chen, M.D.,Ph D. 886-2-2875-7566 chenyj@vghtpe.gov.tw
Principal Investigator: Hsiao-Wen Tsai, M.D.

Sponsors and Collaborators

Taipei Veterans General Hospital,Taiwan

National Yang Ming University

Investigators

Principal Investigator:	Hsiao-Wen Tsai, M.D.	Taipei Veterans General Hospital,Taiwan
Study Chair:	Yi-Jen Chen, M.D., Ph D.	Taipei Veterans General Hospital,Taiwan

More Information

Publications:

Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60.

Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73.

Responsible Party:	Yi-Jen, Chen, M.D., Ph D., Department of Obstetrics and Gynecology, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier:	NCT01433874 History of Changes
Other Study ID Numbers:	100-03-001
Study First Received:	June 14, 2011
Last Updated:	September 13, 2011
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital,Taiwan:

Shoulder pain
Upper abdominal pain
Laparoscopic surgery
Abdominal fullness

Additional relevant MeSH terms:

Nausea
Shoulder Pain
Signs and Symptoms, Digestive
Signs and Symptoms

Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain

ClinicalTrials.gov processed this record on May 23, 2013