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Randomized Controlled Trail for Post Laparoscopic Pain

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Combined maneuver
Intraperitoneal infusion
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shoulder Pain focused on measuring should and upper abdominal pain, post-laparoscopy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Combined maneuver

Intraperitoneal infusion

Control group

Arm Description

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.

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.

CO2 was removed by passive exsufflation through the port site.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 1, 2014
Last Updated
April 16, 2016
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02745574
Brief Title
Randomized Controlled Trail for Post Laparoscopic Pain
Official Title
Prevention of Post-laparoscopic Shoulder and Upper Abdominal Pain: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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, 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
should and upper abdominal pain, post-laparoscopy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined maneuver
Arm Type
Experimental
Arm Description
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.
Arm Title
Intraperitoneal infusion
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
CO2 was removed by passive exsufflation through the port site.
Intervention Type
Procedure
Intervention Name(s)
Combined maneuver
Other Intervention Name(s)
0.9% normal saline and manual pulmonary inflation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal infusion
Other Intervention Name(s)
0.9% normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline pain score of should and upper abdominal pain at 12 hours after surgery
Description
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.
Time Frame
Baseline and 12 hours after surgery
Title
Change from baseline pain score of should and upper abdominal pain at 24 hours after surgery
Description
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.
Time Frame
Baseline and 24 hours after surgery
Title
Change from baseline pain score of should and upper abdominal pain at 48 hours after surgery
Description
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.
Time Frame
Baseline and 48 hours after surgery
Secondary Outcome Measure Information:
Title
Change from baseline of Nause, vomiting and abdominal distention rate at 48 hours after surgery
Description
Secondary outcome measures included the occurrence of nausea or vomiting and abdominal distention.
Time Frame
Baseline and 48 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Jen Chen, M.D., Ph.D.
Email
chenyj@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Jen Chen, M.D., Ph.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taipei
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hsiao Wen Tsai, M.D.
Organizational Affiliation
Taipei Veterans General Hostipal, Taipei
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Jen Chen, M.D., Ph.D.
Email
chenyj@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Hsiao Wen Tsai, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18448749
Citation
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.
Results Reference
result
PubMed Identifier
17043939
Citation
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.
Results Reference
result

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Randomized Controlled Trail for Post Laparoscopic Pain

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