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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group B | Active Comparator | 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. |
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| group S | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guided superficial cervical plexus block | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• American Society of Anesthesiology (ASA) physical status ≥ III.
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| Name | Affiliation | Role |
|---|---|---|
| Sahar Elshall, MD | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Of Medicine- Cairo Univesity | Cairo | 12521 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23035051 | Background | Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3. | |
| 20850082 | Background | Liang S, Irwin MG. Review of anesthesia for middle ear surgery. Anesthesiol Clin. 2010 Sep;28(3):519-28. doi: 10.1016/j.anclin.2010.07.009. Epub 2010 Aug 7. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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study group receives superficial cervical plexus block with lidocaine and bupivacaine control group receives superficial cervical plexus block using normal saline as a placebo
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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 |
| 22971490 | Background | Cai HD, Lin CZ, Yu CX, Lin XZ. Bilateral superficial cervical plexus block reduces postoperative nausea and vomiting and early postoperative pain after thyroidectomy. J Int Med Res. 2012;40(4):1390-8. doi: 10.1177/147323001204000417. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |