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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05186467
Collaborator
(none)
44
1
2
5.1
8.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: intraperitoneal Magnesium sulfate
  • Drug: intravenous magnesium sulfate
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy
Actual Study Start Date :
Sep 2, 2021
Anticipated Primary Completion Date :
Feb 2, 2022
Anticipated Study Completion Date :
Feb 5, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Time for first dose of rescue analgesia [8 hours]

    1st time to feel pain

  2. total analgesic doses [8 hours]

    total (ketorolac) analgesic consumption

Secondary Outcome Measures

  1. post operative pain [8 hours]

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

  2. sedation [8 hours]

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

  3. adverse events [8 hours]

    side effects

  4. serum mgso4 level [2 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fouad Soliman Sohag Egypt 52514

Sponsors and Collaborators

  • Sohag University

Investigators

  • Principal Investigator: Fouad Soliman, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fouad Soliman, Lecturer of Anesthesia and ICU, Sohag University
ClinicalTrials.gov Identifier:
NCT05186467
Other Study ID Numbers:
  • 2007
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fouad Soliman, Lecturer of Anesthesia and ICU, Sohag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022