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

Cairo University (CU)

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Procedure: ultrasound guided superficial cervical plexus block

Study type: Interventional

Funder types: Other

Identifiers

NCT05504551

N-90-2019/MD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

group B

Active Comparator group

Description:

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.

Treatment:

Procedure: ultrasound guided superficial cervical plexus block

group S

Placebo Comparator group

Description:

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.

Treatment:

Procedure: ultrasound guided superficial cervical plexus block