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Status unknownNCT05186467Updated Jan 26, 2022

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

A Phase 2 interventional study of intraperitoneal Magnesium sulfate and intravenous magnesium sulfate in Post Operative Pain, Acute, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 44 Years. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Sohag University · Phase 2, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2021, registered Dec 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Female
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Study 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

02

Conditions studied

  • Post Operative Pain, Acute

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Keywords

  • mgso4,laparoscopy ,intraperitoneal
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 44 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

20-44 years old females, (ASA) class I-II

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Active comparator
    Intraperitoneal magnesium sulfate (IP) group

    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

  • Active comparator
    Intravenous magnesium sulfate (IV) group

    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

Interventions

  • Drugintraperitoneal Magnesium sulfate

    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.

  • Drugintravenous magnesium sulfate

    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.

06

What researchers measure

Primary outcomes

  1. Time for first dose of rescue analgesia

    1st time to feel pain

    Time frame: 8 hours

  2. total analgesic doses

    total (ketorolac) analgesic consumption

    Time frame: 8 hours

Secondary outcomes

  1. post operative pain

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

    Time frame: 8 hours

  2. sedation

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

    Time frame: 8 hours

  3. adverse events

    side effects

    Time frame: 8 hours

  4. serum mgso4 level

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

    Time frame: 2 hours

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05186467
Lead sponsor
Sohag University
Responsible party
Fouad Soliman (Lecturer of Anesthesia and ICU, Sohag University) — Principal investigator
First posted
Jan 11, 2022
Start date
Sep 2, 2021
Primary completion
Feb 2, 2022 (estimated)
Completion
Feb 5, 2022 (estimated)
Last update
Jan 26, 2022

Study contacts

Fouad Soliman, lecturer
Contact
fouad_soliman@med.sohag.edu.eg
01113815186
Soliman
Contact
fouad_soliman@med.sohag.edu.eg
01113815186
Fouad Soliman
principal investigator · Sohag University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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