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Clinical Trials/CTRI/2018/02/011666
CTRI/2018/02/011666CompletedPhase 2

Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for control of shoulder tip pain during Laprascopic Surgery under Spinal Anaesthesia – A Randomised Comparative Trial

Anaesthesia Department1 site in 1 country40 target enrollmentStarted: December 6, 2016Last updated:

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
intra operative opiod requirement

Study Overview

Brief Summary

This study is a randomised comparative trial, investigating the efficacy of performing ultrasound guided superficial cervical plexus block to control the shoulder tip pain, without affecting the diaphragam function, thereby improving patient comfort during laparoscopic surgery under regional anaesthesia.  The primary outcome measure includes comparing the consumption of opioid analgesic during the surgery, between the two groups, which was found to be significantly less in the study group compared to the control group.  The secondary outcome measures include the incidence of conversion to general anaesthesia in which the difference was insignificant, the assessment of diaphragmatic function using ultrasound after performance of the superficial cervical plexus block which was used to correlate the occurrence and intensity of referred shoulder pain during peritoneal insufflation and the patients were found to tolerate the procedure well and there were no complications reported.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • ASA physical status I and II
  • Gynaecological Laparascopic surgeries under 2hours.

Exclusion Criteria

  • Contraindication for spinal anaesthesia
  • Infection in the skin of the neck
  • Height less than 145cms.

Outcomes

Primary Outcomes

intra operative opiod requirement

Time Frame: 2 hours

Secondary Outcomes

  • Diaphragmatic function Assessment by Lloyd’s method(30 minutes)
  • Patient satisfaction
  • Conversion to GA

Investigators

Sponsor
Anaesthesia Department
Sponsor Class
Private medical college

Study Sites (1)

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