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

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

Detailed Description
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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.

Official Title
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Postoperative Analgesic Efficacy of the Pulmonary Recruitment Maneuver Compared to Intraperitoneal Hydrocortisone in Laparoscopic Gynecological Surgery

Conditions
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Laparoscopic Gynecological Surgery

Intervention / Treatment
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* Combination Product: Pulmonary Recruitment Maneuver


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Recruitment Maneuver<br>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<br>* 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<br>|
| Other: Intraperitoneal Hydrocortisone<br>Drug Injection: 100mg of Hydrocortisone will be injected In the peritoneum | Combination Product: Pulmonary Recruitment Maneuver<br>* 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<br>|
| No Intervention: control group<br>In the controls, carbon dioxide will be removed by the traditional passive deflation of abdominal cavity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first 24 hours total analgesic consumption. | Total amount of opioid drugs used after surgery for assessment of post operative pain | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the recovery and hospital stay (hours) | Duration between end of operation and patient discharge from hospital | 24 hours postoperative | 
| Incidence of postoperative nausea ,vomiting or abdominal distension(%) | gastrointestinal complications after surgery | 24 hours postoperative |