Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)

Study Overview
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Brief Summary
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Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups: Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy. Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy

Official Title
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Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy

Conditions
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Post Operative Pain, Acute

Intervention / Treatment
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* Drug: intraperitoneal Magnesium sulfate
* Drug: intravenous magnesium sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-44 years old females, (ASA) class I-II Exclusion Criteria: Patient refusal Allergy to MgSO4 Atrio-ventricular conduction abnormalities Drug abuse Renal or hepatic or cardiovascular dysfunction Prior long-term treatment with calcium channel blockers or magnesium

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraperitoneal magnesium sulfate (IP) group<br>They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then an intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy. | Drug: intraperitoneal Magnesium sulfate<br>* Intraperitoneal (IP) group will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.<br>|
| Active Comparator: Intravenous magnesium sulfate (IV) group<br>They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy. | Drug: intravenous magnesium sulfate<br>* Intravenous (IV) group will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for first dose of rescue analgesia | 1st time to feel pain | 8 hours | 
| total analgesic doses | total (ketorolac) analgesic consumption | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain | The visual analog scale(0-10 with 0 is no pain and 10 is maximum intolerable pain) | 8 hours | 
| sedation | 4 points sedation scale: 0= alert and conscious 1 =quietly awake 2= asleep but easily arousable 3= deep sleep | 8 hours | 
| adverse events | side effects | 8 hours | 
| serum mgso4 level | serum level of mgso4 at end of operation and after 2 hours | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mgso4,laparoscopy ,intraperitoneal