An interventional study of ultrasound guided superficial cervical plexus block in Postoperative Nausea and Vomiting, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
post operative nausea and vomiting are very common after tympanomastoid operations, in this study we are investigating the effect of superficial cervical plexus block on the incidence and severity of those post operative complications.
various treatments and regimens have been tried to overcome the problem of postoperative nausea and vomiting after tympanomastoid surgery. superficial cervical plexus block seems so promising in this regards as it may reduce the incidence and severity of PONV through 3 mechanisms: primarily through blocking vagal afferents to the middle ear which mediate the vomiting reflex, and secondarily through decreasing pain which aggravates PONV, and finally through decreasing intra and post operative opioid consumption due to adequate analgesia which in turn avoids opioids side effects including PONV.
the study group will receive superficial cervical plexus block while the control will receive the same block while given placebo instead of (lidocain/bupivacaine mixture) incidence and severity of PONV will be recoded according to a scale to find the difference between both groups.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 90 is below the median of 115 across 703 interventional studies indexed under Nausea.
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Exclusion Criteria:
American Society of Anesthesiology (ASA) physical status ≥ III.
Superficial cervical plexus block (SCP) block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize superficial cervical plexus (SCP) posterior to the midpoint of sterno cleido mastoid (SCM) muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.
Procedure: ultrasound guided superficial cervical plexus block
SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, 10 ml of normal saline is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.
Procedure: ultrasound guided superficial cervical plexus block
SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) are injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel needle Echogenic Needle.
PONV incidence over 24hour postoperative
incidence of PONV according to PONV score from 0 to 3 where: 0= No nausea,no vomiting, 1= Nausea present, no vomiting, 2= Nausea present, vomiting present, 3= Vomiting\>2 episodes in 30 minutes, i.e., number of patients with PONV score of 0, number of patients with PONV score of 1, number of patients with PONV score of 2 and number of patients with PONV score of 3.
Time frame: 24 hours
post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.
post operative pain is assessed by visual analogue score from 0 to 10. patients are educated that 0= no pain, 5= distressing pain, 10= unbearable pain.
Time frame: up to 24 hours postoperative
Intraoperative and postoperative complications
Complications in the form of bleeding and facial nerve palsy
Time frame: 24 hours
To monitor intraoperative hemodynamics
To monitor intraoperative heart rate and blood pressure
Time frame: up to 4 hours
Side effects and toxicity of drugs
record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension.
Time frame: 24 hours
Need for postoperative analgesia
first analgesic request
Time frame: 24 hours
To detect complications of regional ear block
record complications include (hematoma-facial nerve palsy-oedema)
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Cairo University