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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504551
• Other study ID #: N-90-2019/MD
• Status: Completed
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty Of Medicine- Cairo Univesity	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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