Randomized Controlled Trail for Post Laparoscopic Pain

NCT02745574 | Unknown DMC

• 1 other identifier: 2013-04-038B
• Study Type: interventional
• Target: 360
• 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, 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.

Conditions

Shoulder Pain

Keywords

should and upper abdominal pain, post-laparoscopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change from baseline of Nause, vomiting and abdominal distention rate at 48 hours after surgery

  Baseline and 48 hours after surgery

Study Arms (3)

Combined maneuver

EXPERIMENTAL

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

Intraperitoneal infusion

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 infusion

Control group

NO INTERVENTION

CO2 was removed by passive exsufflation through the port site.

Interventions

Combined maneuver PROCEDURE

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.

Also known as: 0.9% normal saline and manual pulmonary inflation

Combined maneuver

Intraperitoneal infusion 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 0.9% normal saline fluid in the abdominal cavity.

Also known as: 0.9% normal saline

Intraperitoneal infusion

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

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (2)

• 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

MeSH Terms

Conditions

Shoulder Pain; Abdominal Pain

Interventions

Saline Solution; Infusions, Parenteral

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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yi Jen Chen, M.D., Ph.D.

  Taipei Veterans General Hospital, Taipei

  STUDY CHAIR

• Hsiao Wen Tsai, M.D.

  Taipei Veterans General Hostipal, Taipei

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

chenyj@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: YJ Chen, MD, PhD, deaprtment of Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: April 20, 2016
• Study Start: April 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

TW (1)