Intraoperative Use of Analgesics in Tonsillar Fossa and Postoperative Evaluation with Visual analogue Scale Scores-A Prospective, Randomized, Placebo-Controlled, Double-Blind Clinical Trial

THIEME e62 Original Research Intraoperative Use of Analgesics in Tonsillar Fossa and Postoperative Evaluation with Visual analogue Scale Scores—A Prospective, Randomized, PlaceboControlled, Double-Blind Clinical Trial Montasir Junaid1 Muhammad Sohail Halim2 Hareem Usman Khan5 Naeem Sultan Ali6 Maisam Abbas Shiraz Onali3 1 Department of Otolaryngology-Head and Neck Surgery, Armed Forces Hospital Southern Region, Khamis Mushayt, Saudia Arabia 2 Byers Eye Institute, Stanford University, Palo Alto, CA, United States 3 Department of Otorhinolaryngology-Head and Neck Surgery, Jinnah Medical College and Hospital, Karachi, Pakistan 4 Department of Otorhinolaryngology-Head and Neck Surgery, Sir Syed College of Medical Sciences for girls, Karachi, Pakistan 5 Department of Cardiology, Shifa Intersternal Hospital, Islamabad, Pakistan 6 Department of Otolaryngology-Head and Neck Surgery, The Aga Khan Hospital, Dar-es-salaam, Tanzania Sadaf Qadeer4 Address for correspondence Dr. Montasir Junaid, MBBS, FCPS, Department of Otolaryngology-Head and Neck Surgery, Armed Forces Hospital Southern Region, P.O Box: 101, Khamis Mushayt, 61961, Saudia Arabia (e-mail: ). Int Arch Otorhinolaryngol 2020;24(1):e62–e67. Abstract Keywords ► tonsillectomy ► pain ► analgesia Introduction Posttonsillectomy pain results in significant morbidity to the patients. There is a disagreement in the literature regarding the use of local anesthetics during tonsillectomy. The aim of this placebo-controlled, double-blind study is to evaluate the effect of peritonsillar administration of local anesthetics. Objective To evaluate the role of intraoperative use of analgesics in tonsillar fossa and postoperative evaluation with visual analogue scale (VAS) scores in achieving pain relief after tonsillectomy procedure Methods In this study, 180 patients were randomized to 1 of the 6 groups: bupivacaine infiltration, lidocaine infiltration, normal saline infiltration, bupivacaine packing, lidocaine packing, and normal saline packing. Pain caused by speaking, swallowing, and on rest was assessed using VAS at 4, 8, 12, 16 hours, and at discharge. Results Significant analgesia was obtained in patients who received bupivacaine infiltration and packing compared with placebo (p < 0.05). The majority of the study subjects had no postoperative complications, and patients receiving bupivacaine infiltration required less additional analgesics in the first 24 hours after surgery. Conclusion We advocate the use of bupivacaine infiltration or packing immediately following the procedure to achieve adequate postoperative analgesia. Introduction Postoperative analgesia is a vital part of therapy in patients undergoing tonsillectomy. Considering that tonsillectomy is one of the most common otolaryngology procedures, ade- received November 24, 2018 accepted February 17, 2019 DOI https://doi.org/ 10.1055/s-0039-1684037. ISSN 1809-9777. quate postoperative analgesia is essential to decrease morbidity in patients.1,2 The pain peaks immediately after procedure and sustains for the initial three postoperative days.3 Thus, a need of adequate postoperative analgesia is warranted.1,3,4 Copyright © 2020 by Thieme Revinter Publicações Ltda, Rio de Janeiro, Brazil Intraoperative Use of Analgesics in Tonsillar Fossa and Postoperative Evaluation Various practices have been described in the literature to achieve adequate pain control, decrease morbidity, and enhance recovery after tonsillectomy. These include preoperative topical administration of local anesthetics, nerve blockade, use of dexamethasone, opioids, acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), perioperative hydration, family education, and different surgical approaches.1,2,4–6 Systemic analgesics and opioids provide pain relief, but this therapy is associated with increase in postoperative nausea, vomiting and constipation, which can lead to decreased oral intake and dehydration. The alternative is to use a local anesthetic agent to achieve adequate pain control. Bupivacaine is a potent analgesic that produces rapid and sustained analgesia.7–9 It has been used as a peripheral nerve block and for prevention of postoperative pain following tonsillectomy.10–13 Lidocaine is a common local anesthetic agent that is widely used. Lidocaine has been utilized in management of posttonsillectomy pain.14,15 Local infiltration of local anesthetic agents in the tonsillar fossa is known to produce complications due to inadvertent intravascular injection,16 whereas topical application is considered safe and simple to perform. Pre and postoperative local anesthetic agents like bupivacaine and lignocaine have been utilized in the literature as infiltration in the tonsillar fossa with conflicting results. However, due to the scarcity of data on the effect of local anesthetic agents on posttonsillectomy pain control, we aimed to evaluate the role of local anesthetic agents, in injectable and topical form, in achieving adequate pain relief after the tonsillectomy procedure. Methodology Study Design This prospective, randomized, double-blind clinical trial was conducted at a tertiary care hospital in Karachi, Pakistan, over a period of 3 years (Jan 2012-Dec 2015). Institutional ethical review committee approval and informed written consent were obtained prior to the enrollment. A minimal sample size calculation showed 13 patients to be recruited in each arm of the study, but to bring the sample size to a normal distribution 30 participants in each arm were enrolled. Thus, a total of 180 patients were recruited for the purpose of this study. Randomization and Intervention Patients were presented with six unidentified papers to choose from with preassigned codes for each group. Patients were randomized to one of the six (6) therapies: bupivacaine infiltrate, lidocaine infiltrate, normal saline infiltrate, bupivacaine pack, lidocaine pack, and normal saline pack. Each group had 30 patients. A clinical nurse was assigned to prepare the codes and for infiltration or pack and, then, to provide it to the operating surgeon in an unlabeled sealed envelope before the procedure. Since all the analgesic agents were clear liquids, there was no way for the surgeon or patient to know which agent u placed in the envelope. The infiltration or pack was administered at the completion of surgery, just before extuba- Junaid et al. tion. No patient was given systemic analgesics in the first 24 hours after surgery. Two (2) ward nurses were trained to ask about the visual analogue scale (VAS) scores from patients at different intervals (4, 8, 12 and 16 hours postoperatively) until the time they were discharged. These findings were noted in a separate questionnaire. (See ►Proforma - available online) All patients were operated with diathermy to minimize confounders in the study. Patient Eligibility Patients undergoing elective tonsillectomy at a tertiary care hospital in Karachi, Pakistan, were eligible for the study. (...truncated)