Pre-Emptive Analgesia in Dental Implant Surgery

NCT03243032 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 201707814
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the clinical effectiveness of combined use of pre-emptive analgesia and long acting anesthesia for pain suppression following dental implant surgery as measured by a validated numerical rating scale and the information related to consumption of post-operative medications.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Post-operative pain as measured by numerical rating scale

  Difference in pain scores between test and control groups during the time points assessed (0 min, 30, 60, 90, 120, 150, 180, 210, 240 minutes and 24 hours) will be analyzed.

  24 hours

Secondary Outcomes (6)

• Total pain medication consumption between test and control

  14 days

• Time duration to take first pain medication between test and control

  14 days

• Post-operative pain with anterior versus posterior site of surgery

  24 hours

• Post-operative pain as it correlates with the duration of the surgical procedure

  24 hours

• Pre-surgical anxiety correlated with post-surgical pain

  24 hours

Study Arms (2)

Local Anesthetic Group 1

EXPERIMENTAL

Group 1 (Pre-emptive analgesia with long acting local anesthesia - experimental group): Ibuprofen 600mg given 30 minutes prior to beginning of surgery. Surgery will be performed only using 0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic. Following the procedure, all patients will be prescribed Chlorhexidine rinse ( 0.12%) (Rinse with 15 ml two times a day and spit) for 10 days and Antibiotics: Amoxicillin 500 mg three times a day for 7 days or if allergic to penicillin, clindamycin 300 mg four times a day for 7 days. Ibuprofen (600 mg) q 6 hours: prn for pain will be provided to all patients at no charge. Tramadol 50 mg (one every 4-6 hours as needed for pain; maximum 400 mg/day) for uncontrolled pain.

Drug: Ibuprofen 600 mg; Drug: Local anesthetic Group 1

Local Anesthetic Control

PLACEBO COMPARATOR

Group 2 (Control / standard of care group): Placebo oral capsule (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery. Surgery will be performed using 2% lidocaine with 1:100,000 epinephrine as the local anesthesia. Following the procedure, all patients will be prescribed Chlorhexidine rinse ( 0.12%) (Rinse with 15 ml two times a day and spit) for 10 days and Antibiotics: Amoxicillin 500 mg three times a day for 7 days or if allergic to penicillin, clindamycin 300 mg 4 times a day for 7 days. Ibuprofen (600 mg) q 6 hours: prn for pain will be provided to all patients at no charge. Tramadol 50 mg (one every 4-6 hours as needed for pain; maximum 400 mg/day) for uncontrolled pain.

Drug: Placebo oral capsule; Drug: Local anesthetic Control

Interventions

Ibuprofen 600 mg DRUG

Ibuprofen 600mg given 30 minutes prior to beginning of surgery

Also known as: non-steroidal anti-inflammatory (NSAID)

Local Anesthetic Group 1

Local anesthetic Group 1 DRUG

0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic for Group 1 Experimental.

Also known as: anesthesia

Local Anesthetic Group 1

Placebo oral capsule DRUG

Placebo (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery

Also known as: Placebo - Microcrystalline Cellulose NF (Avicel PH 105)

Local Anesthetic Control

Local anesthetic Control DRUG

2% lidocaine with 1:100,000 epinephrine as the local anesthetic for Group 2 - Control

Also known as: anesthesia

Local Anesthetic Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients 18 years of age and under 65 years of age
• ASA Type I \& II
• Single tooth edentulous site requiring dental implant placement without any additional bone or soft tissue augmentation at the time of implant placement
• Patients not requiring use of any form of sedation for dental implant surgery (nitrous, oral or IV sedation)

You may not qualify if:

• Hypersensitivity to NSAIDs, salicylates, or microcrystalline cellulose NF (Avicel PH 105)
• Liver disease
• Renal disease
• Hypertension and taking angiotensin-converting-enzyme inhibitors and/or diuretics
• Significant respiratory conditions including acute or severe asthma.
• Cardiovascular disease that will prevent the patient from going through the surgical procedure or consuming the required medications: cardiac disease, cardiomyopathy, cardiac arrhythmias, coronary heart disease, acute MI, angina, history of MI, coronary artery bypass grafting (CABG), Aspirin intake, peripheral vascular disease, cerebral vascular disease (stroke, TIA)
• Gastrointestinal disease including irritable bowel disease and gastric ulcers
• Hematological diseases (coagulopathy, hemophilia or thrombocytopenia)
• Pregnancy/lactation at the time of surgery
• Heavy smoking (\>10 cigarettes per day)
• Diabetes
• Allergies or intolerance to ibuprofen, opioids, and local anesthetic (lidocaine and bupivacaine)
• History of recreational drug abuse
• History of heavy alcohol use. Substance Abuse and Mental Health Services Administration (SAMSHA)30 defines heavy alcohol use as binge drinking on 5 or more days in the past month. SAMSHA defines binge drinking as 5 or more alcoholic drinks for males or 4 or more alcoholic drinks for females on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month.
• Patients currently taking prescription pain medications or have taken over-the-counter pain medications within 4 days of surgery.

Sponsors & Collaborators

• Satheesh Elangovan: lead

Study Sites (1)

Univerity of Iowa College of Dentsitry Dental Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Anesthesia and Analgesia

Study Officials

• Sathesh Elangovan, BDS

  University of Iowa College of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not know which arm they will be in initially. At the 2 week post-operative visit they may be notified of which arm they participated in if they so choose to find out.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, parallel arms, double-blinded, placebo-controlled trial

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 8, 2017
• Study Start: October 6, 2017
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)