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Analgesic Effect of Pulmonary Recruitment and Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery

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ClinicalTrials.gov Identifier: NCT03845608
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mina Adolf Helmy, Cairo University

Brief Summary:
The aim of this study is to compare the postoperative analgesic efficacy of intraperitoneal hydrocortisone to pulmonary recruitment maneuver in Laparoscopic gynaecological surgery.

Condition or disease Intervention/treatment Phase
Laparoscopic Gynecological Surgery Combination Product: Pulmonary Recruitment Maneuver Phase 4

Detailed Description:

Laparoscopic surgeries are becoming more attractive because of an early recovery . However, post laparoscopic shoulder and upper abdominal pain may cause more discomfort to the patient than the pain at the incision site.

Proper pain relief is a major concern and area of focus. Pre-operatively, one of the most common questions asked by patients about the amount of pain they will experience after the surgery. Pain has been found to be one of the three most common medical causes of delayed discharge after ambulatory surgery, the other two being drowsiness and nausea and vomiting. Unfortunately prevention and treatment of postoperative pain continues to be a major challenge in postoperative care.

Good pain control after surgery is important to prevent negative outcomes such as tachycardia, hypertension, myocardial ischemia, decrease in alveolar ventilation, and poor wound healing.

Pain also can prolong hospital stay, which is particularly important in day case procedures.

The mechanism of laparoscopy induced shoulder pain is mainly derived from carbon dioxide retention within the abdomen, subsequently irritating the phrenic nerve and causing referred pain in the C4 dermatome. Moreover, carbon dioxide trapped between the liver and the right diaphragm, irritating the diaphragm, also causes upper abdominal pain.

Although there are many analgesic drugs available for postoperative pain, many patients still find them to be suboptimal for controlling pain.

Many strategies, including treatment with non steroidal anti-inflammatory drugs, have been used to try to reduce laparoscopy-induced shoulder pain however, no sufficiently reliable methods have been reported yet .

Also Intraperitoneal local anesthetic was tried as an important addition for postoperative pain in the era of modern surgery. The method of delivering local anesthetic directly to the intraperitoneal cavity was first described in 1951 by Griffin et al. ; however, this method was forgotten for many years until its implementation in minimal access surgery was reappeared. It significantly reduces postoperative pain and opioid consumption after laparoscopic gynecological and general surgical operations.

Another effective method is the pulmonary recruitment maneuver (PRM) which can mechanically remove residual carbon dioxide and therefore decreasing peritoneal irritation, and shoulder pain.

Intravenous steroids have been used successfully for postoperative pain relief in different kinds of surgery . Also intraperitoneal hydrocortisone was has been used effectively to reduce pain after laparoscopic cholecystectomy.

In addition combination of intraperitoneal local anesthetics with hydrocortisone was proved to be a successful method in controlling upper abdominal and shoulder pain after laparoscopic procedures.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Analgesic Efficacy of the Pulmonary Recruitment Maneuver Compared to Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: Pulmonary Recruitment Maneuver
Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity
Combination Product: Pulmonary Recruitment Maneuver
Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity.recieve100 mg hydrocortisone in 250 ml normal saline at end of surgery and carbon dioxide will be removed by applying gentle abdominal pressure and removing carbon dioxide by passive exsufflation

Intraperitoneal Hydrocortisone
Drug Injection: 100mg of Hydrocortisone will be injected In the peritoneum
Combination Product: Pulmonary Recruitment Maneuver
Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity.recieve100 mg hydrocortisone in 250 ml normal saline at end of surgery and carbon dioxide will be removed by applying gentle abdominal pressure and removing carbon dioxide by passive exsufflation

No Intervention: control group
In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity.



Primary Outcome Measures :
  1. The first 24 hours total analgesic consumption. [ Time Frame: 24 hours after surgery ]
    Total amount of opioid drugs used after surgery for assessment of post operative pain


Secondary Outcome Measures :
  1. Length of the recovery and hospital stay (hours) [ Time Frame: 24 hours postoperative ]
    Duration between end of operation and patient discharge from hospital

  2. Incidence of postoperative nausea ,vomiting or abdominal distension(%) [ Time Frame: 24 hours postoperative ]
    gastrointestinal complications after surgery



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • female gender, age 20-45 years undergoing laparoscopic gynecological operations

    • American Society of Anesthesiologist physical status classification of I or II

Exclusion Criteria:

  • • Patients younger than 20 years or older than 45 years

    • History of chronic pain
    • Regular medication with analgesics, or steroids
    • Analgesic use within 24 h of surgery ,drug or alcohol abuse
    • Associated chronic diseases like diabetes mellitus, pulmonary diseases ,poor cardiac reserve,hepatorenal insufficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845608


Contacts
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Contact: Atef Abdelmawla 01286970031 dratef@rocketmail.com
Contact: Nesrine El-Refai, MD 01001775623 nesrinerefai@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Nesrine El-Refai, MD Cairo University

Publications:
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Responsible Party: Mina Adolf Helmy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03845608     History of Changes
Other Study ID Numbers: pain and laparoscopic surgery
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Analgesics
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents