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Clinical Trials/CTRI/2024/03/064513
CTRI/2024/03/064513
Not yet recruiting
Phase 1

Pain management after Robot-Assisted minimally invasive esophagectomy,comparison of analgesic efficacy of IV PCA morphine and epidural Levobupivacaine with fentanyl

Rajiv Gandhi Cancer Institute & Research Center Delhi1 site in 1 country50 target enrollmentStarted: March 28, 2024Last updated:
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Overview

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Rajiv Gandhi Cancer Institute & Research Center Delhi
Enrollment
50
Locations
1
Primary Endpoint
Compare VAS pain score to assess postoperative analgesia between two study group
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is the study to compare the analgesic effectiveness and hemodynamic changes of continuous epidural infusion of 0.0625% Levobupivacaine with fentanyl 2mcg/ml in one group and IVPCA morphine in other group fpr Postoperative analgesia  In Robot-assisted minimally invasive esophagectomy. Rescue analgesia will be provided with intravenous injection 50 mg tramadol.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patient undergoing Robotic esophagectomy Patients willing to use IV Patient control Analgesia.

Exclusion Criteria

  • •Patient refusal for epidural catheter placement ASA physical status 3 or more.

Outcomes

Primary Outcomes

Compare VAS pain score to assess postoperative analgesia between two study group

Time Frame: Every 6 hourly on postoperative day then every 12 hourly for next 4 days till epidural catheter in situ or ivPCA morphine till 4th postop day

Secondary Outcomes

  • Requirement of rescue analgesia doses and total volume of drug used for epidural infusion and in IVPCA group(Every 6 hourly on postoperative day then every 12 hourly for next 4 days till epidural catheter in situ or ivPCA morphine till 4th postop day)

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center Delhi
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Vishal Bhatnagar

Rajiv Gandhi Cancer Institute & Research Center,Rohini, New Delhi

Study Sites (1)

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