Randomized Controlled Trail for Post Laparoscopic Pain

Prevention of Post-laparoscopic Shoulder and Upper Abdominal Pain: A Randomized Controlled Trial.

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, we should try to do is that if we 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: Shoulder Pain
• Intervention / Treatment: Procedure: Combined maneuver; Procedure: Intraperitoneal infusion

Detailed Description

All the patients will receive laparoscopic surgery using carbon dioxide (CO2 ) gas as distension medium. At the end of the surgery, in the control group C, CO2 was removed by passive exsufflation through the port site. In the intervention group A, at the end of the surgery, 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. Then, patients will be placed in the Trendelenburg position (30 degrees), and a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anesthesiologists held the fifth positive pressure inflation for approximately 5 seconds. During these maneuvers, the surgeon was instructed to ensure that the trocar sleeve valve was fully open to allow the CO2 gas to escape.

In the intervention group B, at the end of the surgery, 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.

Patients will be asked to fill out questionnaires up to 48 hours to determine the frequency and severity of their shoulder and upper abdominal pain. The scores will be assessed 12, 24, 48 hours after surgery using a visual analogue scale( VAS) from 0 ( no pain) to 10 ( worst possible pain).

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Yi Jen Chen, M.D., Ph.D.; Email: chenyj@vghtpe.gov.tw
    • Principal Investigator: Hsiao Wen Tsai, M.D.

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: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined maneuver; Combined maneuver: 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. Then, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm dihydrogen monoxide (H2O). The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.	Procedure: Combined maneuver; Combined maneuver (Intraperitoneal normal saline infusion and Pulmonary recruitment maneuver): 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 0.9% normal saline fluid in the abdominal cavity. Then, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.; Other Names: 0.9% normal saline and manual pulmonary inflation
Experimental: Intraperitoneal infusion; 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 infusion; 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 0.9% normal saline fluid in the abdominal cavity.; Other Names: 0.9% normal saline
No Intervention: 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
Change from baseline pain score of should and upper abdominal pain at 12 hours after surgery	The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder and upper abdominal pain. Thus the primary outcome measure of this trial is the severity and frequency of their should and upper abdominal pain. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12 hours after surgery. VAS consists of a subjective evaluation of the pain on a scale of 10 in which 0 is no pain and 10 the most severe pain.	Baseline and 12 hours after surgery
Change from baseline pain score of should and upper abdominal pain at 24 hours after surgery	The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder and upper abdominal pain. Thus the primary outcome measure of this trial is the severity and frequency of their should and upper abdominal pain. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 24 hours after surgery. VAS consists of a subjective evaluation of the pain on a scale of 10 in which 0 is no pain and 10 the most severe pain.	Baseline and 24 hours after surgery
Change from baseline pain score of should and upper abdominal pain at 48 hours after surgery	The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder and upper abdominal pain. Thus the primary outcome measure of this trial is the severity and frequency of their should and upper abdominal pain. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 48 hours after surgery. VAS consists of a subjective evaluation of the pain on a scale of 10 in which 0 is no pain and 10 the most severe pain.	Baseline and 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Nause, vomiting and abdominal distention rate at 48 hours after surgery	Secondary outcome measures included the occurrence of nausea or vomiting and abdominal distention.	Baseline and 48 hours after surgery

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Yi Jen Chen, M.D., Ph.D., Taipei Veterans General Hospital, Taipei; Principal Investigator: Hsiao Wen Tsai, M.D., Taipei Veterans General Hostipal, Taipei

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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: September 1, 2014
• First Submitted That Met QC Criteria: April 16, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 16, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: should and upper abdominal pain, post-laparoscopy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2013-04-038B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED