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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05186467

Enrollment

Registered

2022-01-11

Start date

2021-09-02

Completion date

2022-02-05

Last updated

2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain, Acute

Keywords

mgso4,laparoscopy ,intraperitoneal

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 44 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
adverse events	8 hours	side effects
serum mgso4 level	2 hours	serum level of mgso4 at end of operation and after 2 hours

Countries

Egypt

Contacts

Primary ContactFouad Soliman, lecturer

fouad_soliman@med.sohag.edu.eg01113815186

Backup ContactSoliman