Skip to content

Postoperative Analgesia in Laparoscopic Gynecological Surgeries

Magnesium Sulfate Versus Sodium Bicarbonate as Adjuvants to Lidocaine 1% by Intraperitoneal Instillation for Postoperative Analgesics in Laparoscopic Gynecological Surgeries

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06491485
Enrollment
90
Registered
2024-07-09
Start date
2024-10-01
Completion date
2025-12-01
Last updated
2024-07-09

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

Conditions

Postoperative Pain

Keywords

Laparoscopic gynecological surgeries

Brief summary

The aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

Detailed description

Patients undergoing laparoscopic surgery experience postoperative pain especially in the abdomen, lower back, and shoulders, Relieving postoperative pain, especially with certain types of analgesic agents, may reduce postoperative morbidity and mortality. It is also important to prevent adverse events such as myocardial infarction, cardiac arrhythmia, ileus, and poor wound healing and pulmonary complications. There is evidence that the main source of pain after laparoscopic surgeries is the peritoneum . Due to CO2 insufflation constitutes the commonest means of creating the pneumoperitoneum. Co2pneumoperitoneum is known to cause systemic acidosis. Which is responsible for damaging of the mesothelial lining of the peritoneum and consequent peritoneal irritation . Moreover, the phrenic nerve could be damaged by the acidic environment The use of local anesthetics has been advocated as a method for reducing postoperative pain local anesthetic intraperitoneal administration has shown good effects on reducing postoperative pain in laparoscopic cholecystectomy and gynecological surgeries . intraperitoneal sodium bicarbonate instillation may neutralize effect of the acid milieu on peritoneal cavity and the phrenic nerve damage which consecutively will lead to a reduction of postoperative pain. Magnesium sulfate, a non-competitive NMDA antagonist, has been proven in animal and human being models to have antinociceptive properties. The antinociceptive effect of magnesium sulfate relieves chronic pain and it can also decrease the duration and intensity of postoperative pain.

Interventions

DRUGGroup M (lidocaine with Magnesium sulfate)

a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with magnesium sulfate 50 mg/kg (maximum 2g) will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

DRUGGroup B (lidocaine with Sodium bicarbonate)

a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine with 50 ml 4.2% sodium bicarbonate will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

DRUGGroup C (lidocaine with saline)

a total volume 200 ml normal saline 0.9% at a temperature of 37°c including 3mg/kg of 1% lidocaine will be sprayed by the surgeon through the laparoscopic port to wash the incisions and anastomosis.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* age 18:60years * patients undergoing laparoscopic gynecological surgeries, * ASA 1&2

Exclusion criteria

* patient dissatisfaction for participating in the study * opioid use within 24 hr before the study * allergy to the drugs used in the study and alcohol use * chronic pain syndrome. * neurological disease. * steroid treatment * conversion of laparoscopic surgery to open surgery * use a drain

Design outcomes

Primary

MeasureTime frameDescription
first rescue analgesia24 hour postoperativeThe first request for analgesia will be recorded by the nurse, and in case of pain in VAS more than 3, 1 gm of paracetamol will be administrated as a rescue analgesic if failed fentanyl 100mic will be added

Contacts

Primary ContactMahmoud Hamza Abd elrady, M.B.B.Ch
mh401022@gmail.com01020643396
Backup ContactNoha Hassan Abdelghany, M.D.
noha@aun.edu.eg01069009221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026