Reducing Shoulder Tip Pain Following Laparoscopic Surgery

NCT01135836 | Unknown Phase 3 DMC

• 1 other identifier: VGHIRB No. 980705
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 reduce carbon dioxide retention in the pelvic cavity.

Conditions

Shoulder Pain; Laparoscopic Surgery

Keywords

Shoulder pain; Gynecologic laparoscopic surgery; Nausea; Vomiting; Abdominal fullness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nausea or abdominal fullness after laparoscopic surgery

  the first 48 hours after the surgery

Study Arms (3)

pulmonary recruitment maneuver

EXPERIMENTAL

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

intraperitoneal normal saline

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

CO2 was removed by passive exsufflation through the port site.

Procedure: Control group

Interventions

Pulmonary recruitment maneuver PROCEDURE

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.

pulmonary recruitment maneuver

Intraperitoneal normal saline PROCEDURE

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.

intraperitoneal normal saline

Control group PROCEDURE

CO2 was removed by passive exsufflation through the port site.

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 22184293 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Nausea; Vomiting

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yi-Jen Chen, Ph.D,

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

• Hsiao-Wen Tsai, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Jen Chen, Ph.D.

CONTACT

886-2-28757566; chenyj@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 3, 2010

Record last verified: 2010-06

Locations

TW (1)