Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

NCT01433874 | Unknown Phase 3 DMC

• 1 other identifier: 100-03-001
• Study Type: interventional
• Target: 200
• 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 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.

Conditions

Shoulder Pain; Nausea

Keywords

Shoulder pain; Upper abdominal pain; Laparoscopic surgery; Abdominal fullness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• nausea or abdominal fullness after laparoscopic surgery

  The first 38 hours after the surgery

Study Arms (4)

Pulmonary recruitment maneuver

EXPERIMENTAL

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

Intraperitoneal normal saline infusion

EXPERIMENTAL

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

combined group

EXPERIMENTAL

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

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 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.

Pulmonary recruitment maneuver

Intraperitoneal normal saline infusion PROCEDURE

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

Intraperitoneal normal saline infusion

combined group PROCEDURE

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.

combined group

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 gynecological 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 (3)

• 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.

  PMID: 18448749 RESULT

• 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.

  PMID: 17043939 RESULT

• 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.

  PMID: 23635614 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Nausea; Abdominal Pain

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

• Hsiao-Wen Tsai, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Yi-Jen Chen, M.D., Ph D.

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

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

CONTACT

886-2-2875-7566; chenyj@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: September 14, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 14, 2011

Record last verified: 2011-07

Locations

TW (1)