Reducing Shoulder Tip Pain Following Laparoscopic Surgery

A Randomized, Controlled, Single Blind Study Comparing a Pulmonary Recruitment Maneuver Versus Intraperitoneal Infusion of Normal Saline to Reduce Shoulder Tip Pain After Gynecologic Laparoscopic Surgery

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 reduce carbon dioxide retention in the pelvic cavity.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Surgery; Shoulder Pain
• Intervention / Treatment: Procedure: Pulmonary recruitment maneuver; Procedure: Intraperitoneal normal saline; Procedure: Control group

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yi-Jen Chen, Ph.D.; Phone Number: 886-2-28757566; Email: chenyj@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Yi-Jen Chen, Ph.D.; Phone Number: 886-2-28757566; Email: chenyj@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients receive benign gynaecological 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pulmonary recruitment maneuver; a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist 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 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.
Experimental: intraperitoneal normal saline; the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity	Procedure: Intraperitoneal normal saline; the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the severity and frequency of shoulder-tip pain after laparoscopic surgery	We will follow the patients in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder-tip pain after laparoscopic surgery. The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder-tip pain after laparoscopic surgery.	the first 48 hours after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea or abdominal fullness after laparoscopic surgery	Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.	the first 48 hours after the surgery

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Yang Ming University
• Investigators: Study Chair: Yi-Jen Chen, Ph.D,, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 3, 2010
• Last Update Submitted That Met QC Criteria: June 2, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Shoulder pain; Gynecologic laparoscopic surgery; Abdominal fullness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: VGHIRB No. 980705