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

Phase 2

• Conditions: Post Operative Pain, Acute
• Interventions: Drug: intraperitoneal Magnesium sulfate; Drug: intravenous magnesium sulfate

• Registration Number: NCT05186467
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2021-12-29
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-26
• Primary Completion: 2022-02-02
• Study Completion: 2022-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraperitoneal magnesium sulfate (IP) group	intraperitoneal Magnesium sulfate	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.
Intravenous magnesium sulfate (IV) group	intravenous magnesium sulfate	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.

Primary Outcome Measures

Name	Time	Method
Time for first dose of rescue analgesia	8 hours	1st time to feel pain
total analgesic doses	8 hours	total (ketorolac) analgesic consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fouad Soliman; 🇪🇬 Sohag, Egypt