Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

Maneuvers to Decrease Upper and Shoulder 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 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.

Study Overview

• Status: Unknown
• Conditions: Nausea; Shoulder Pain
• Intervention / Treatment: Procedure: Pulmonary recruitment maneuver; Procedure: Intraperitoneal normal saline infusion; Procedure: combined group; Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yi-Jen Chen, M.D., Ph D.; Phone Number: 886-2-2875-7566; Email: chenyj@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Yi-Jen Chen, M.D.,Ph D.; Phone Number: 886-2-2875-7566; 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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
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.
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 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

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 38 hours after the surgery

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Yang Ming University

Publications and helpful links

General 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. doi: 10.1097/AOG.0b013e31816e34b4.
• 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. doi: 10.1007/s00268-005-0752-z.
• Tsai HW, Wang PH, Yen MS, Chao KC, Hsu TF, Chen YJ. Prevention of postlaparoscopic shoulder and upper abdominal pain: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):526-531. doi: 10.1097/AOG.0b013e318283fcca.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: September 13, 2011
• First Posted (ESTIMATE): September 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 14, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Shoulder pain; Upper abdominal pain; Abdominal fullness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 100-03-001