Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief

Analgesia Clinical Trial

Official title:

Ultrasound-Guided Submandibular Parapharyngeal Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief in Adults. A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435833
• Other study ID #: GPN block in tonsillectomy
• Status: Completed
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: August 1, 2023

Study information

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

Clinical Trial 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

Description:

Tonsillectomy is one of the most frequent surgical procedures performed all over the world that has been identified as being severely painful especially in the adult population. Management of post tonsillectomy pain is of paramount importance in order to improve swallowing and enhance oral intake as well as to decrease the risk of dehydration, infection and secondary hemorrhage with a subsequent hastening of recovery.

A variety of analgesic regimens have been implemented to alleviate post-tonsillectomy pain, however; no consensus on the ideal analgesic regimen has been yet identified.

The Ultrasound (US)-guided glossopharyngeal nerve (GPN) block has been acknowledged as a feasible option for providing perioperative analgesia in tonsillectomy patients. It blocks sensory impulses from the posterior third of the tongue, palatine tonsil, and mucous membranes of the mouth and pharynx. Conventional techniques for blocking the GPN carry the risk of vascular puncture, inadvertent block of closely adjacent other cranial nerves, with increased probability of local anesthetic toxicity and even upper airway obstruction. Recently, a novel, safe, and reproducible US-guided GPN block technique has been introduced by Azman et al, which would block the GPN distally, in the tissue plane just next to the pharyngeal wall and relatively far from high risk nearby structures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients classified by the American society of Anesthesiologists ASA I and II patients

• Scheduled for tonsillectomy procedure

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• bilateral ultrasound guided GPN block
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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbia

Sponsors (4)

Lead Sponsor	Collaborator
Tanta University	Aliaa Muhammad Belal, Gehan Morsy Eid, Mohamed Shebl Abdelghany

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of 1st analgesic request	the time to first analgesic request will be recorded	up to 24 hours postoperative
Secondary	Pain score	The numerical rating scale for pain ranging from 0-10 where the minimum value of 0 represents no pain and the maximum value of 10 represent the worst pain imaginable	at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperative
Secondary	Postoperative rescue analgesic consumption	Total 24 hours postoperative rescue analgesic consumption	up to 24hours postoperative