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Clinical Trials/CTRI/2024/09/073782
CTRI/2024/09/073782Not yet recruitingPhase 3 4

Comparison between sodium bicarbonate and dexamethasone as adjuncts to levobupivacaine for post operative analgesia, given via ultrasound guided lateral quadratus lumborum block for hip surgery.

Uttar Pradesh University of Medical Sciences1 site in 1 country60 target enrollmentStarted: September 15, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
1.Duration of analgesia.

Study Overview

Brief Summary

The ideal peripheral nerve block technique for hip arthroplasty should achieve adequate sensory block without affecting motor function. The sensory afferent of the hip joint arise from several branches of lumbar plexus. Ultrasound guided quadratus lumborum block has been described as an analgesic technique in abdominal surgeries as well as in various lower limb surgeries (lateral or posterior QL block). It is performed through the injection of a local anaesthetic mixture between the lateral abdominal layers and QL muscle. The peculiar feature of this block is that it not only sensory nerves but also the visceral nerves. Peripheral nerve blocks provide longer and localized pain relief with early ambulation and also avoid the side effects of systemic medication. The major limiting factor with the use of local anaesthetic are their short duration of action and delayed onset. To overcome these shortcomings, adjuvant such as opioids, magnesium, ketamine etc have been used. In this study we will compare the duration of analgesia with two adjuvants dexamethasone and sodium bicarbonate with levobupivacaine.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

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

Inclusion Criteria

  • ASA physical status 1 and
  • Elective hip surgery under subarachnoid block.

Exclusion Criteria

  • Patients with a history of allergy to drugs used in the study .
  • Any history of substance abuse .
  • Body mass index (BMI) ≥30 .
  • Patients with psychosis/gross neurological disorders.

Outcomes

Primary Outcomes

1.Duration of analgesia.

Time Frame: 1.After the block is give we will note the very first time when VAS4 and measure the VAS score at an interval of 4 hours till 24 hours. | 2.After the 24 hours from the time block is given we will see the satisfaction score.

2.Quality of analgesia.

Time Frame: 1.After the block is give we will note the very first time when VAS4 and measure the VAS score at an interval of 4 hours till 24 hours. | 2.After the 24 hours from the time block is given we will see the satisfaction score.

Secondary Outcomes

  • 1.Hemodynamic parameters.(2.Total need for rescue analgesia over 24 hours.)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Mehak Gupta

UPUMS, Saifai, Etawah

Study Sites (1)

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