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Analgesic Effect of IntraPeritoneal LIGNOcaine in Gynaecological Open Surgery

NCT05897385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-01-27

No results posted yet for this study

Summary

The incidence of postoperative pain is highly prevalent among surgical patients. Inadequate postoperative pain control can slow the recovery and it increases the risk of postoperative complications, namely lung collapse and chronic pain. Although morphine is the one of the gold standard analgesia option for postoperative pain, it comes with many unwanted adverse effects, such as severe nausea and vomiting, low blood pressure and dizziness. Thus, multimodal analgesia regime, including local anaesthetic (lignocaine) is strongly advocated for postoperative analgesia.

The normal route of lignocaine is injected into vein for the properties of analgesia and anti-inflammatory. It exerts its effect via the systemic absorption of drugs to block the central neuronal pain transmission. In recent years, studies have demonstrated that instillation of lignocaine inside abdominal cavity can reduce internal organ pain by blocking free nerve ending inside abdomen with minimal systemic absorption of drug and lower complications of systemic toxicity of local anaesthesia as compared to the intravenous route of lignocaine.

Several RCTs showed the beneficial effect of intraperitoneal lignocaine for the reduction of postoperative visceral pain after laparoscopic surgery. However, gynaecological open surgery (cystectomy, hysterectomy) involves greater degree of manipulation and trauma on the internal organs with greater visceral pain, resulting in longer duration of hospitalisation and delayed functional mobility recovery. It is believed that the intraperitoneal lignocaine reduces inflammatory response after surgery and exert analgesia effect by blocking the neural signal transmission at site of tissue injury. Therefore, it is important to conduct this study to examine the analgesic effect of intraperitoneal lignocaine in women undergoing gynaecological open surgery.

Conditions

  • Postoperative Pain
  • Gynecologic Disease
  • Local Anesthetic Systemic Toxicity

Interventions

DRUG

Lignocaine

Intraperitoneal lignocaine 200mg/20mls + epinephrine 1:200,000

DRUG

Normal Saline

Intraperitoneal 20ml of 0.9% normal saline

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Pui San Loh, MBBS · University of Malaya

  • Ka Ting Ng, MBChB · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2026-01-08
Completion
2026-01-08

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05897385 on ClinicalTrials.gov