Back to results

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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

ultrasound guided superficial cervical plexus block

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring nause, vomiting, tympanomastoid operations

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Faculty Of Medicine- Cairo Univesity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

group B

group S

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Intraoperative and postoperative complications

Complications in the form of bleeding and facial nerve palsy

To monitor intraoperative hemodynamics

To monitor intraoperative heart rate and blood pressure

Side effects and toxicity of drugs

record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension.

Need for postoperative analgesia

first analgesic request

To detect complications of regional ear block

record complications include (hematoma-facial nerve palsy-oedema)

Full Information

NCT ID

NCT05504551

First Posted

August 14, 2022

Last Updated

February 14, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05504551

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 31, 2022 (Actual)

Primary Completion Date

January 1, 2023 (Actual)

Study Completion Date

January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

nause, vomiting, tympanomastoid operations

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group B

Arm Type

Active Comparator

Arm Description

Arm Title

group S

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ultrasound guided superficial cervical plexus block

Intervention 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, 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.

Primary Outcome Measure Information:

Title

PONV incidence over 24hour postoperative

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

up to 24 hours postoperative

Title

Intraoperative and postoperative complications

Description

Complications in the form of bleeding and facial nerve palsy

Time Frame

24 hours

Title

To monitor intraoperative hemodynamics

Description

To monitor intraoperative heart rate and blood pressure

Time Frame

up to 4 hours

Title

Side effects and toxicity of drugs

Description

record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension.

Time Frame

24 hours

Title

Need for postoperative analgesia

Description

first analgesic request

Time Frame

24 hours

Title

To detect complications of regional ear block

Description

record complications include (hematoma-facial nerve palsy-oedema)

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sahar Elshall, MD

Organizational Affiliation

Cairo University

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty Of Medicine- Cairo Univesity

City

Cairo

ZIP/Postal Code

12521

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23035051

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.

Results Reference

background

PubMed Identifier

20850082

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.

Results Reference

background

PubMed Identifier

22971490

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs