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

NCT05504551 | Completed

• 1 other identifier: N-90-2019/MD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

nause, vomiting, tympanomastoid operations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.

  up to 24 hours postoperative

• Intraoperative and postoperative complications

  24 hours

• To monitor intraoperative hemodynamics

  up to 4 hours

• Side effects and toxicity of drugs

  24 hours

• Need for postoperative analgesia

  24 hours

Study Arms (2)

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.

Procedure: ultrasound guided superficial cervical plexus block

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.

Procedure: ultrasound guided superficial cervical plexus block

Interventions

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.

group B; group S

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients belonging to American Society of Anesthesiologists physical status I-II.
• operation time less than 4 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty Of Medicine- Cairo Univesity

Cairo, 12521, Egypt

Location

Related 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.

  PMID: 23035051 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.

  PMID: 20850082 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.

  PMID: 22971490 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Sahar Elshall, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care medicine- Faculty of Medicine

Model Details: study group receives superficial cervical plexus block with lidocaine and bupivacaine control group receives superficial cervical plexus block using normal saline as a placebo

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 17, 2022
• Study Start: August 31, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)