Clinical trial NCT05435833: Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief
Official title: Ultrasound-Guided Submandibular Parapharyngeal Glossopharyngeal Nerve Block for Post -Tonsillectomy Pain Relief in Adults. A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Gehan Morsy Eid
name: Aliaa Muhammad Belal
name: Mohamed Shebl Abdelghany
First posted: 2022-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Onset of 1st analgesic request
timeFrame: up to 24 hours postoperative
Secondary outcomes:
measure: Pain score
timeFrame: at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours postoperative
measure: Postoperative rescue analgesic consumption
timeFrame: up to 24hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
affiliation: Tanta University
name: Mona B El Mourad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.