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Clinical Trials/CTRI/2020/12/030121
CTRI/2020/12/030121Not yet recruitingPhase 3 4

comparative study of efficacy of intraperitoneal instillation of 0.2% ropivacaine with dexmedetomidine versus 0.2% ropivacaine with ketamine in laparoscopic surgeries - a randomized study

DUDYALA DHATRI1 site in 1 country105 target enrollmentStarted: January 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
105
Locations
1
Primary Endpoint
To study the total duration of analgesia and total rescue analgesic dose requirements in first 24 hours post operatively.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Postoperative pain management in laparoscopic surgeries plays a very crucial role in Enhanced Recovery After Surgery. Intraperitoneal instillation of local anesthetic will block the free nerve endings in the peritoneum and thus provide relief from visceral pain.

In this study one group will receive 0.2 % Ropivacaine (30ml) with 0.5mcg/kg Dexmedetomidine (1ml) and other group will receive 0.2 % Ropivacaine (30ml) with 0.5mg/kg Ketamine (1ml). Control group will receive 0.2 % Ropivacaine (30ml) with normal saline (1ml).Three groups will be compared in terms of intensity of static and dynamic pain by VAS score for first 24 hours postoperatively. The total duration of analgesia and total analgesic dose will be compared in three groups.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •PATIENTS WITH ASA PS I & II POSTED FOR ELECTIVE LAPAROSCOPIC SURGERIES.

Exclusion Criteria

  • •Patient refusal Local anesthetic allergy / drug allergy Pregnancy Patients with Cardiovascular/Respiratory/ Liver/ Renal diseases BMI ≥ 30 Kg/m2 If any other surgeries combined in the same sitting.

Outcomes

Primary Outcomes

To study the total duration of analgesia and total rescue analgesic dose requirements in first 24 hours post operatively.

Time Frame: for every 30 min for first two hours and then at 6 hours,12 hours and 24 hours.

Secondary Outcomes

  • The hemodynamic parameters intraoperatively and postoperatively.(Incidence of postoperative nausea and vomiting using Likert scale.)

Investigators

Sponsor
DUDYALA DHATRI
Sponsor Class
Other []

Study Sites (1)

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