Comparision of two different techniques for control of pain during abdominal cancer surgeries.

Active, not recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/12/038518
• Lead Sponsor: DR BRAIRCH AIIMS NEW DELHI

Brief Summary

Poorly controlled postoperative pain is a majorrisk factor for the development of chronic postoperative pain. It has an impact on patient’s quality of life. Recently there hasbeen a trend towards use of multimodal analgesic technique due to the adverse effectsof opioids like respiratory depression, excessive sedation, pruritus and nauseavomiting. The anesthesiologist’s armamentarium formanagement of postoperative pain has dramatically increased in the recent pastwith the availability of a plethora of drugs and techniques. The varioustechniques include regional anesthesia and use of a multimodal analgesicregimen with increased emphasis on the use of analgesic adjuvants likeketamine, lignocaine, dexmedetomidine and gabapentin or pregabalin. Amongvarious techniques, epidural analgesia is considered asthe gold standard for both intraoperative and postoperative analgesia inabdominal surgeries. However, epidural technique has its own side effects likeneuraxial hematoma, infection, trauma to spinal cord and injury to nerve root.Additionally, epidural catheter placement may be difficult in some patients.There is limited data on the use of a combination of intravenous lignocaine,ketamine and dexmedetomidine as a part of opioid free multimodal analgesicregimen. Hencein this study we aim to compare the analgesic efficacy of the multimodalintravenous technique to that of the epidural technique, in terms ofpostoperative pain assessment by Numeric Rating Scale score in both the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age of 18 years or older, but less than 70 years.
• Posted for elective oncological abdominal surgeries.
• Patients giving consent for the procedure.

Exclusion Criteria

• Complicated with mental illness which could interfere with the evaluation of pain scores.
• Severe heart disease (NYHA classification ≥3) 3.
• History of epilepsy 4.
• Any renal or hepatic disorder before surgery.
• Contraindications of epidural anesthesia.
• Allergic to any drug used during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessment using Numerical rating scale (NRS).	After shifting to ICU, 1, 2, 4, 8, 12, 18 and 24 hours in the post-operative period.

Secondary Outcome Measures

Name	Time	Method
Pain assessment using NRS during coughing/deep breathing	After shifting to ICU, 1, 2, 4, 8, 12, 18 and 24 hours in the post-operative period.
To compare postoperative IV fentanyl consumption by PCA	24 hours
To compare intraoperative IV fentanyl consumption	Intraoperative period
To compare intraoperative hemodynamic parameters (SBP, DBP, MAP & HR)	Intraoperative period
To compare other postoperative parameters (sedation score, time to first flatus, movement out of bed, postoperative nausea and vomiting)	Till the day of discharge
Any other complications in the IV group	Till the day of discharge
Any other complications in the Epidural group	Till the day of discharge

Trial Locations

Locations (1)

DR BRA.IRCH, AIIMS, NEW DELHI; 🇮🇳 West, DELHI, India

DR BRA.IRCH, AIIMS, NEW DELHI

🇮🇳West, DELHI, India

GITARTHA GOSWAMI

Principal investigator

9864081045

gitarthaamc@gmail.com