Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Superficial Cervical Plexus Block on Incidence and Severity of Post Operative Nausea and Vomiting in Tympanomastoid Operations in Adults, Randomized Controlled Study

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Procedure: ultrasound guided superficial cervical plexus block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients belonging to American Society of Anesthesiologists physical status I-II. operation time less than 4 hours. Exclusion Criteria: • American Society of Anesthesiology (ASA) physical status ≥ III. Uncooperative or mentally retarded patients. Known Allergy or hypersensitivity to lidocaine or bupivacaine. Patients known to have gastritis or Gastro-oesophageal reflux disease (GERD). History of PONV or motion sickness. Operation duration (short less than 30 minutes or prolonged more than 240 min). Patients with chronic renal disease (serum creatinine level ≥2.0mg/dl) or on renal replacement therapy (dialysis). Patients with chronic cholecystitis (history of recurrent or persistent vomiting) Skin inflammation and cellulitis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: study group receives superficial cervical plexus block with lidocaine and bupivacaine control group receives superficial cervical plexus block using normal saline as a placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group B<br>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<br>* 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.<br>|
| Placebo Comparator: group S<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 24 hours postoperative | 
| Intraoperative and postoperative complications | Complications in the form of bleeding and facial nerve palsy | 24 hours | 
| To monitor intraoperative hemodynamics | To monitor intraoperative heart rate and blood pressure | up to 4 hours | 
| Side effects and toxicity of drugs | record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension. | 24 hours | 
| Need for postoperative analgesia | first analgesic request | 24 hours | 
| To detect complications of regional ear block | record complications include (hematoma-facial nerve palsy-oedema) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nause, vomiting, tympanomastoid operations