Clinical trial NCT05504551: Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations
Official title: Effect of Superficial Cervical Plexus Block on Incidence and Severity of Post Operative Nausea and Vomiting in Tympanomastoid Operations in Adults, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: nause, vomiting, tympanomastoid operations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PONV incidence over 24hour postoperative
timeFrame: 24 hours
Secondary outcomes:
measure: post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.
timeFrame: up to 24 hours postoperative
measure: Intraoperative and postoperative complications
timeFrame: 24 hours
measure: To monitor intraoperative hemodynamics
timeFrame: up to 4 hours
measure: Side effects and toxicity of drugs
timeFrame: 24 hours
measure: Need for postoperative analgesia
timeFrame: 24 hours
measure: To detect complications of regional ear block
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Of Medicine- Cairo Univesity
Study officials:
affiliation: Cairo University
name: Sahar Elshall, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.