Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief

NCT05435833 | Completed

• 1 other identifier: GPN block in tonsillectomy
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the efficacy and safety of Ultra-sound guided submandibular parapharyngeal glossopharyngeal nerve block as regards time for first need of analgesic as a primary outcome as well as pain score, total postoperative analgesic requirement, and incidence of complications as secondary outcomes

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Onset of 1st analgesic request

  the time to first analgesic request will be recorded

  up to 24 hours postoperative

Secondary Outcomes (2)

• Pain score

  at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperative

• Postoperative rescue analgesic consumption

  up to 24hours postoperative

Study Arms (2)

Group I (glossopharyngeal nerve block group)

EXPERIMENTAL

bilateral ultrasound guided GPN block will be performed after induction of anesthesia and pre incisional by an experienced anesthesiologist

Procedure: bilateral ultrasound guided GPN block

Group II(Control group)

NO INTERVENTION

general anesthesia alone (no block)

Interventions

bilateral ultrasound guided GPN block PROCEDURE

a linear high frequency ultrasound probe will be initially positioned over the hyoid bone in the transverse plane, then the probe will be rotated to keep in line with the mandibular angle and the pharyngeal wall is identified by US. Using an in plane approach, a 22 G ,5 cm needle will be advanced till it reaches just superficial to the pharyngeal wall and 2.2 ml of 0.25% bupivacaine will be injected.

Group I (glossopharyngeal nerve block group)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients classified by the American society of Anesthesiologists ASA I and II patients
• Scheduled for tonsillectomy procedure

You may not qualify if:

• Patients' refusal
• History of diabetes mellitus,
• Cardiac, liver or renal impairment
• Obstructive sleep apnea syndrome
• Swallowing difficulty
• Intake of chronic pain medications or substance abuse
• Bleeding disorders
• Hypersensitivity to the used medication

Sponsors & Collaborators

• Tanta University: lead
• Gehan Morsy Eid: collaborator
• Aliaa Muhammad Belal: collaborator
• Mohamed Shebl Abdelghany: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 31599, Egypt

Location

Related Publications (13)

• Kim MS, Choi HG, Park EK, Kim SY, Kim JH, Park B. Natural course of tonsillectomy pain: A prospective patient cohort study. Auris Nasus Larynx. 2018 Jun;45(3):508-513. doi: 10.1016/j.anl.2017.07.018. Epub 2017 Sep 8.

  PMID: 28890114 BACKGROUND

• Ahmed SA, Omara AF. The Effect of Glossopharyngeal Nerve Block on Post-Tonsillectomy Pain of Children; Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 30;9(2):e90854. doi: 10.5812/aapm.90854. eCollection 2019 Apr.

  PMID: 31341828 BACKGROUND

• Ozalevli M, Unlugenc H, Tuncer U, Gunes Y, Ozcengiz D. Comparison of morphine and tramadol by patient-controlled analgesia for postoperative analgesia after tonsillectomy in children. Paediatr Anaesth. 2005 Nov;15(11):979-84. doi: 10.1111/j.1460-9592.2005.01591.x.

  PMID: 16238560 BACKGROUND

• Naesh O, Niles LA, Gilbert JG, Ammar MM, Phibbs PW, Phillips AM, Khrapov AV, Robert AJ, McClintock A. A randomized, placebo-controlled study of rofecoxib with paracetamol in early post-tonsillectomy pain in adults. Eur J Anaesthesiol. 2005 Oct;22(10):768-73. doi: 10.1017/s0265021505001274.

  PMID: 16211736 BACKGROUND

• Hanasono MM, Lalakea ML, Mikulec AA, Shepard KG, Wellis V, Messner AH. Perioperative steroids in tonsillectomy using electrocautery and sharp dissection techniques. Arch Otolaryngol Head Neck Surg. 2004 Aug;130(8):917-21. doi: 10.1001/archotol.130.8.917.

  PMID: 15313860 BACKGROUND

• Kaygusuz I, Susaman N. The effects of dexamethasone, bupivacaine and topical lidocaine spray on pain after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2003 Jul;67(7):737-42. doi: 10.1016/s0165-5876(03)00091-0.

  PMID: 12791448 BACKGROUND

• Ginstrom R, Silvola J, Saarnivaara L. Local bupivacaine-epinephrine infiltration combined with general anesthesia for adult tonsillectomy. Acta Otolaryngol. 2005 Sep;125(9):972-5. doi: 10.1080/00016480510043413.

  PMID: 16193589 BACKGROUND

• Aldamluji N, Burgess A, Pogatzki-Zahn E, Raeder J, Beloeil H; PROSPECT Working Group collaborators*. PROSPECT guideline for tonsillectomy: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Jul;76(7):947-961. doi: 10.1111/anae.15299. Epub 2020 Nov 17.

  PMID: 33201518 BACKGROUND

• Tolska HK, Hamunen K, Takala A, Kontinen VK. Systematic review of analgesics and dexamethasone for post-tonsillectomy pain in adults. Br J Anaesth. 2019 Aug;123(2):e397-e411. doi: 10.1016/j.bja.2019.04.063. Epub 2019 Jun 17.

  PMID: 31221427 BACKGROUND

• Sirohiya P, Kumar V, Yadav P, Bharti SJ. Ultrasound-Guided Glossopharyngeal Nerve Block at Pharyngeal Wall Level in a Patient with Carcinoma Tongue. Indian J Palliat Care. 2020 Jan-Mar;26(1):140-141. doi: 10.4103/IJPC.IJPC_132_19. Epub 2020 Jan 28.

  PMID: 32132800 BACKGROUND

• Manoharan D, Bharati SJ, Yadav MK. A novel technique of ultrasound-guided glossopharyngeal nerve block to relieve cancer pain. Saudi J Anaesth. 2019 Jul-Sep;13(3):279-280. doi: 10.4103/sja.SJA_139_19. No abstract available.

  PMID: 31333392 BACKGROUND

• Bean-Lijewski JD. Glossopharyngeal nerve block for pain relief after pediatric tonsillectomy: retrospective analysis and two cases of life-threatening upper airway obstruction from an interrupted trial. Anesth Analg. 1997 Jun;84(6):1232-8. doi: 10.1097/00000539-199706000-00011.

  PMID: 9174298 BACKGROUND

• Azman J, Stopar Pintaric T, Cvetko E, Vlassakov K. Ultrasound-Guided Glossopharyngeal Nerve Block: A Cadaver and a Volunteer Sonoanatomy Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):252-258. doi: 10.1097/AAP.0000000000000561.

  PMID: 28195898 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mona B El Mourad, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 28, 2022
• Study Start: November 5, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

EG (1)