Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

Shoulder Pain Clinical Trial

Official title:

Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01433874
• Other study ID #: 100-03-001
• Status: Recruiting
• Phase: Phase 3
• First received: June 14, 2011
• Last updated: September 13, 2011
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2011
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Yi-Jen Chen, M.D., Ph D.
• Phone: 886-2-2875-7566
• Email: chenyj[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Shoulder Pain

Intervention

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.
• 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
• 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.
• Control group
Co2 was removed by passive exsufflation through the port site.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. doi: 10.1097/AOG.0b013e31816e34b4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery	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.	The first 48 hours after the surgery	Yes
Secondary	nausea or abdominal fullness after laparoscopic surgery	postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded.	The first 38 hours after the surgery	Yes