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Completed

NCT Number: NCT06966596

Low-Dose Ketamine Infusion for Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy

Following surgery, acute pain is a typical issue with a variety of implications. Surgeons, anesthesia specialists, and patients all desire effective pain management with the fewest possible adverse effects. At low dosages (<0.3 mg/kg/hr) and large doses (>1 mg/kg), ketamine is utilized as an analgesic and an anaesthetic. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. Although this medication is a powerful analgesic, its usage is restricted due to it leads to agitation and hallucinations during awakening. Nevertheless, it has a potent analgesic effect when administered at a subanesthetic dose, and ketamine's psychomimetic side effects are rare at these dosages. This study intended to examine the role of low-dose for post-operative pain control in patients undergoing LC, despite the fact that numerous studies have been conducted on the subject and that the results have been inconsistent.

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Key information

Conditions

Laparoscopic Cholecystectomy Agnosia Biliary Tract Diseases Cholelithiasis Digestive System Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fazaia Ruth Pfau Medical College, PAF Hospital Base Faisal

Karachi, Pakistan

About this study

Most patients still stay overnight after a laparoscopic cholecystectomy (LC) due to post-operative pain, which continues to be the principal obstacle to early patient discharge. On the first postoperative day following laparoscopic procedures, patients may have mild to moderate postoperative pain, with decreased pain intensity in the shoulder area (from the subdiaphragmatic region), particularly intra-abdominal and local discomfort at the incision site. Because of its analgesic properties and cardiovascular stability, ketamine has been used extensively in anesthesia practice. It non-competitively blocks N-methyl-D-aspartate (NMDA) receptors. As an addition to multimodal perioperative pain management, ketamine has grown in favor in recent years. Ketamine at high dosages causes dissociative anaesthesia with little impact on breathing or airway reflexes. In a range of surgical procedures, low-dose ketamine infusions (<0.3 mg/kg/hr) have demonstrated effectiveness in lowering pain scores and minimising the need for postoperative opioids. Regarding the reduction of pain and analgesic demand, ketamine has demonstrated conflicting effects. The study objective was to determine the effect of low-dose ketamine infusion on quality and duration of post-operative pain in patients undergoing laparoscopic in a tertiary care hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of age 18 years or above of either gender
  • Patients planned of elective laparoscopic choleycyctectomy

Exclusion criteria

  • Obese patients
  • History of alcohol consumption and drug abusers
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Patients with chronic pain
  • Patients allergic to study drugs
  • Patients with neurological disorders
  • Patients unable to understand scoring system

Treatment and study plan

Ketamine only

Drug

Group A received ketamineat 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. W

Placebo Normal Saline (NS)

Other

Control group received normal saline to maintain double blinding

Primary outcomes

  1. Post-pain assessment

    Time frame: pain status was monitored post-operatively at 0 hour, 2 hour, 4 hours, 6 hours, 12 hours and at 24 hours

    pain was assessed using numeric rating scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no pain and 10 means worst pain.

Secondary outcomes

  1. time to rescue analgesia

    Time frame: till 24 hours post-operatively

    time to rescue analgesia was defined as time point at which patient was given rescue analgesia for pain score of 5 or above

Sponsors and collaborators

Lead sponsor

Fazaia Ruth Pfau Medical College

Other

Registry information

Official study title

Effect of Low-Dose Ketamine Infusion on Quality and Duration of Post-Operative Pain in Patients Undergoing Laparoscopic Cholecyctectomy Under General Anesthesia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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