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

Primary Purpose

Post Operative Pain, Acute

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

intraperitoneal Magnesium sulfate

intravenous magnesium sulfate

About this trial

This is an interventional health services research trial for Post Operative Pain, Acute focused on measuring mgso4,laparoscopy ,intraperitoneal

Eligibility Criteria

20 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Fouad SolimanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intraperitoneal magnesium sulfate (IP) group

Intravenous magnesium sulfate (IV) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time for first dose of rescue analgesia

1st time to feel pain

total analgesic doses

total (ketorolac) analgesic consumption

Secondary Outcome Measures

post operative pain

The visual analog scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)

sedation

4 points sedation scale: 0= alert and conscious 1 =quietly awake 2= asleep but easily arousable 3= deep sleep

adverse events

side effects

serum mgso4 level

serum level of mgso4 at end of operation and after 2 hours

Full Information

NCT ID

NCT05186467

First Posted

December 29, 2021

Last Updated

January 10, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05186467

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 2, 2021 (Actual)

Primary Completion Date

February 2, 2022 (Anticipated)

Study Completion Date

February 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain, Acute

Keywords

mgso4,laparoscopy ,intraperitoneal

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraperitoneal magnesium sulfate (IP) group

Arm Type

Active Comparator

Arm Description

Arm Title

Intravenous magnesium sulfate (IV) group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

intraperitoneal Magnesium sulfate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

intravenous magnesium sulfate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time for first dose of rescue analgesia

Description

1st time to feel pain

Time Frame

8 hours

Title

total analgesic doses

Description

total (ketorolac) analgesic consumption

Time Frame

8 hours

Secondary Outcome Measure Information:

Title

post operative pain

Description

The visual analog scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)

Time Frame

8 hours

Title

sedation

Description

4 points sedation scale: 0= alert and conscious 1 =quietly awake 2= asleep but easily arousable 3= deep sleep

Time Frame

8 hours

Title

adverse events

Description

side effects

Time Frame

8 hours

Title

serum mgso4 level

Description

serum level of mgso4 at end of operation and after 2 hours

Time Frame

2 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

44 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fouad Soliman, lecturer

Phone

01113815186

fouad_soliman@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Soliman

Phone

01113815186

fouad_soliman@med.sohag.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fouad Soliman

Organizational Affiliation

Sohag University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fouad Soliman

City

Sohag

ZIP/Postal Code

52514

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fouad Soliman

Phone

01113815186

fouad_soliman@med.sohag.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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