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

NCT05186467 | Unknown Phase 2 DMC

• 1 other identifier: 2007
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain, Acute

Keywords

mgso4,laparoscopy ,intraperitoneal

Outcome Measures

Primary Outcomes (2)

• Time for first dose of rescue analgesia

  1st time to feel pain

  8 hours

• total analgesic doses

  total (ketorolac) analgesic consumption

  8 hours

Secondary Outcomes (4)

• post operative pain

  8 hours

• sedation

  8 hours

• adverse events

  8 hours

• serum mgso4 level

  2 hours

Study Arms (2)

Intraperitoneal magnesium sulfate (IP) group

ACTIVE COMPARATOR

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

Intravenous magnesium sulfate (IV) group

ACTIVE COMPARATOR

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

intraperitoneal Magnesium sulfate DRUG

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.

Intraperitoneal magnesium sulfate (IP) group

intravenous magnesium sulfate DRUG

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.

Intravenous magnesium sulfate (IV) group

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old females, (ASA) class I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Fouad Soliman

Sohag, 52514, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fouad Soliman

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fouad Soliman, lecturer

CONTACT

01113815186; fouad_soliman@med.sohag.edu.eg

Soliman

CONTACT

01113815186; fouad_soliman@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and ICU

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 11, 2022
• Study Start: September 2, 2021
• Primary Completion: February 2, 2022
• Study Completion: February 5, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

EG (1)