Intraperitoneal lavage with normal saline containing bupivacaine, normal saline containing magnesium sulfate, and normal saline alone in patients candidate for colon cancer surgery.

Comparison of the effectiveness of intraperitoneal lavage of normal saline containing bupivacaine, normal saline containing magnesium sulfate, and normal saline alone on postoperative complications in patients with colon cancer: a randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260214068852N1

Enrollment

105

Registered

2026-05-24

Start date

2026-06-22

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

In patients who are candidates for colon cancer surgery.

Interventions

Intervention 1: Intervention group (A): Intraperitoneal lavage with 30 ml of 0.25% bupivacaine without normal saline. Intervention 2: Intervention group (B): Intraperitoneal lavage with 30 ml of 10%

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older Confirmed diagnosis of non-metastatic colon adenocarcinoma based on preoperative histopathological biopsy Candidates for non-emergency radical resection surgery, with or without stoma creation Feasibility of primary anastomosis during surgery (where applicable) Acceptable functional status classified as ASA physical status I, II, or III Provision of written informed consent Scheduled for open laparotomy

Exclusion criteria

Exclusion criteria: Known hypersensitivity or allergy to bupivacaine or magnesium sulfate History of cardiac surgery Left Ventricular Ejection Fraction (LVEF) 1 month prior to surgery. Severe cognitive, psychiatric, or language disorders impeding pain assessment or provision of informed consent. Drug addiction Refusal to provide informed consent. Myocardial infarction within the last 6 weeks. Severe liver failure or cirrhosis.

Design outcomes

Primary

Measure	Time frame
Postoperative surgical site pain. Timepoint: 2, 4, 6, 12, and 24 hours after surgery. Method of measurement: Using the Visual Analogue Scale.;Night sleep quality. Timepoint: Up to 72 hours after surgery and up to three measurements. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;The incidence of neurotoxicity (paresthesia, motor or sensory blockade, seizures, respiratory failure, drowsiness). Timepoint: The first 24 hours after surgery. Method of measurement: Clinical examination and recording of incidence among individuals.;Number of times housing applications were made. Timepoint: The first 24 hours after surgery. Method of measurement: Counting the number of times housing applications are made.;Incidence of gastrointestinal complications(nausea, vomiting, cramps or abdominal pain). Timepoint: The first 24 hours after surgery. Method of measurement: Clinical examination and recording of incidence among individuals.	—

Measure

Time frame

Postoperative surgical site pain. Timepoint: 2, 4, 6, 12, and 24 hours after surgery. Method of measurement: Using the Visual Analogue Scale.;Night sleep quality. Timepoint: Up to 72 hours after surgery and up to three measurements. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;The incidence of neurotoxicity (paresthesia, motor or sensory blockade, seizures, respiratory failure, drowsiness). Timepoint: The first 24 hours after surgery. Method of measurement: Clinical examination and recording of incidence among individuals.;Number of times housing applications were made. Timepoint: The first 24 hours after surgery. Method of measurement: Counting the number of times housing applications are made.;Incidence of gastrointestinal complications(nausea, vomiting, cramps or abdominal pain). Timepoint: The first 24 hours after surgery. Method of measurement: Clinical examination and recording of incidence among individuals.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSina Ghasemi

Hamedan University of Medical Sciences

sinaghasemi19980@gmail.com+98 901 669 0780

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026