Pain, Postoperative Clinical Trial
Official title:
Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions.
NCT number | NCT04860141 |
Other study ID # | 5200474 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 16, 2021 |
Est. completion date | July 2025 |
This study is a double-blind, randomized, prospective, placebo-controlled single-center clinical research study in which 600 mg of gabapentin or placebo will be administered 2 hours preoperatively to 49 patients each undergoing wisdom teeth extraction. We will measure intraoperative opioid use, severity of pain, the number of analgesics taken, and side effect profiles (e.g. nausea/vomiting, dizziness) at the following intervals, 4 hour, 8 hour, 12 hour, 24, and 72 hour post-procedure.
Status | Recruiting |
Enrollment | 98 |
Est. completion date | July 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | Inclusion Criteria: - Subjects must be at or older than 18. - Screened body mass index (BMI) between 18-35 kg/m2. - American Society of Anesthesiologists Classification I and II. - Subjects must be willing and able to comply with protocol requirements. - Subjects must be able to understand the informed consent and must be able to sign a written informed consent form prior to the initiation of any study procedures. - A subject must have at least 1 partial or fully impacted third molar tooth removal. Exclusion Criteria: - hypersensitivity to gabapentinoids; - history of chronic opioid or gabapentin usage (regular use of opioids >3 months) - history of recreational drug usage - a history or clinical manifestations of significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, musculoskeletal, psychiatric, or immunologic disorder, any acute, clinically significant illness or condition within 14 days prior to Day 1. - Patients with baseline pain. - Patients with any oral pathology will be excluded. - Pregnant or breastfeeding patients - An individual not legally competent to consent (e.g., incapacitated individuals, incompetents, minors) |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Health | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Crisologo PA, Monson EK, Atway SA. Gabapentin as an Adjunct to Standard Postoperative Pain Management Protocol in Lower Extremity Surgery. J Foot Ankle Surg. 2018 Jul-Aug;57(4):781-784. doi: 10.1053/j.jfas.2018.02.005. Epub 2018 May 7. — View Citation
Felder L, Saccone G, Scuotto S, Monks DT, Carvalho JCA, Zullo F, Berghella V. Perioperative gabapentin and post cesarean pain control: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Feb;233:98-106. doi: 10.1016/j.ejogrb.2018.11.026. Epub 2018 Dec 12. — View Citation
Grover VK, Mathew PJ, Yaddanapudi S, Sehgal S. A single dose of preoperative gabapentin for pain reduction and requirement of morphine after total mastectomy and axillary dissection: randomized placebo-controlled double-blind trial. J Postgrad Med. 2009 Oct-Dec;55(4):257-60. doi: 10.4103/0022-3859.58928. — View Citation
Han C, Li XD, Jiang HQ, Ma JX, Ma XL. The use of gabapentin in the management of postoperative pain after total knee arthroplasty: A PRISMA-compliant meta-analysis of randomized controlled trials. Medicine (Baltimore). 2016 Jun;95(23):e3883. doi: 10.1097/MD.0000000000003883. Erratum In: Medicine (Baltimore). 2016 Jul 18;95(28):e0916. — View Citation
Quintero GC. Review about gabapentin misuse, interactions, contraindications and side effects. J Exp Pharmacol. 2017 Feb 9;9:13-21. doi: 10.2147/JEP.S124391. eCollection 2017. — View Citation
Salama ER, Amer AF. The effect of pre-emptive gabapentin on anaesthetic and analgesic requirements in patients undergoing rhinoplasty: A prospective randomised study. Indian J Anaesth. 2018 Mar;62(3):197-201. doi: 10.4103/ija.IJA_736_17. — View Citation
Sanders JG, Dawes PJ. Gabapentin for Perioperative Analgesia in Otorhinolaryngology-Head and Neck Surgery: Systematic Review. Otolaryngol Head Neck Surg. 2016 Dec;155(6):893-903. doi: 10.1177/0194599816659042. Epub 2016 Jul 26. — View Citation
Turan A, Memis D, Karamanlioglu B, Yagiz R, Pamukcu Z, Yavuz E. The analgesic effects of gabapentin in monitored anesthesia care for ear-nose-throat surgery. Anesth Analg. 2004 Aug;99(2):375-8, table of contents. doi: 10.1213/01.ANE.0000136646.11737.7B. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | opioid use | assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes. | 4 hour postoperatively | |
Primary | opioid use | assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes. | 8 hour postoperatively | |
Primary | opioid use | assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes. | 12 hour postoperatively | |
Primary | opioid use | assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes. | 48 hour postoperatively | |
Primary | opioid use | assess the number of opioid pills (norco 5/325mg) taken postoperatively. #of pills that a patient takes. | 72 hour postoperatively | |
Primary | intraoperative fentanyl use | assess amount of fentanyl given intraoperatively. mcg of fentanyl given in a case. | during the surgical procedure | |
Secondary | pain control | assess amount of pain that the patient is in by using modified brief pain index. (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity) | 4 hour postoperatively | |
Secondary | pain control | assess amount of pain that the patient is in by using modified brief pain index. (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity) | 8 hour postoperatively | |
Secondary | pain control | assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity) | 12 hour postoperatively | |
Secondary | pain control | assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity) | 24 hour postoperatively | |
Secondary | pain control | assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity) | 48 hour postoperatively | |
Secondary | pain control | assess amount of pain that the patient is in by using modified brief pain index (0 is no pain at all, 10 is the worst pain- interfering with one's everyday activity) | 72 hour postoperatively | |
Secondary | nausea | If the pt is having nausea any time within 72hrs. Yes or No. | within 72 hour postoperatively | |
Secondary | Vomiting | If the pt is having vomiting any time within 72hrs. Yes or No. | within 72 hour postoperatively | |
Secondary | Dizziness | If the pt is having dizziness any time within 72hrs. Yes or No. | within 72 hour postoperatively | |
Secondary | Drowsiness | If the pt is having drowsiness any time within 72hrs. Yes or No. | within 72 hour postoperatively | |
Secondary | pain interfering in general activity | 0 is not interference at all, 10 is severely interfering with life. | within 72 hours postoperatively | |
Secondary | pain interfering in mood | pain interfering in mood; 0 is not interference at all, 10 is severely interfering with life. | within 72 hours postoperatively | |
Secondary | pain interfering in normal work | pain interfering in normal work; 0 is not interference at all, 10 is severely interfering with life. | within 72 hours postoperatively | |
Secondary | pain interfering in relations with other people | pain interfering in relations with other people; 0 is not interference at all, 10 is severely interfering with life. | within 72 hours postoperatively | |
Secondary | pain interfering in sleep | pain interfering in sleep; 0 is not interference at all, 10 is severely interfering with life. | within 72 hours postoperatively | |
Secondary | pain interfering in enjoyment in life | pain interfering in enjoyment in life; 0 is not interference at all, 10 is severely interfering with life. | within 72 hours postoperatively |
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