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POSTOPERATIVE PAIN MANAGEMENT USING BUPIVACAINE AFTER MANDIBULAR ORTHOGNATHIC SURGERY: A TRIPLE-BLINDED RANDOMIZED CONTROLLED CLINICAL TRIAL

POSTOPERATIVE PAIN MANAGEMENT USING BUPIVACAINE AFTER MANDIBULAR ORTHOGNATHIC SURGERY: A TRIPLE-BLINDED RANDOMIZED CONTROLLED CLINICAL TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200128007
Enrollment
28
Registered
2020-01-28
Start date
2020-01-20
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after mandibular orthognathic surgery postoperative pain, Bupivacaine, BSSRO, orthognathic surgery, pain control

Interventions

Bupivacaine is an amide type of local anesthetic agent&#44
first prepared by A.F. Ekenstam in 1957 AD. Food and Drug Administration (FDA) approved in October 1972 AD.It is available as a 0.5% solution with 1: 200&#44
000 epinephrine. FDA maximum recommended dose (MRD) is 90 mg. It has a slower onset of action than other commonly used local anesthetics (6&#45
10 min) which is understandable in view of its pKa of 8.1. It is metabolized in liver by amidases and excretion through kidney. It is categorized as pregnancy classification C. A randomize&#44
crossover clinical study by Jennifer christen et al [49] compared postoperative analgesic effect between bupivacaine and lidocaine after surgical removal of mandibular third molar and the result showe
and 0.5% bupivacaine with 1:200&#44
000 adrenaline in 20 patients who underwent surgical removal of impacted mandibular third molar teeth by chapman et al [51]. This study involved a double&#45
blind cross&#45
over trial and approximately 2 mL was used for the inferior alveolar block and another 1 mL for buccal infiltration. No premedication was used. The mean analgesic requirements over the first 12 hours
Experimental Drug,Placebo Comparator Other

Sponsors

Faculty of Dentistry, Mahidol University, Thailand
Lead Sponsor
Faculty of Dentistry&#44
Collaborator
Mahidol University&#44
Collaborator
Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologist (ASA): class I and II 2. Patients undergoing Bilateral Sagittal Split Osteotomy (BSSRO) of mandible only without complication. - Mandibular advancement or setback

Exclusion criteria

Exclusion criteria: 1. All the patients with any history of allergy to local anesthetics, opioid, NSAID or any of the medications being administered. 2. Patients with a history of narcotic or alcohol abuse. 3. Patients with a history of chronic debilitating disease. 4. Chronic opioid analgesic use. 5. Pregnancy and lactating mother. 6. Patients undergoing both jaw surgery (lefort 1 + BSSRO) or Lefort 1 only

Design outcomes

Primary

MeasureTime frame
Postoperative analgesic efficacy of bupivacaine 24 hour Numeric Rating Scale (NRS) for pain,Amount of rescue medicine needed for postoperative pain control 24 hour total milligram

Secondary

MeasureTime frame
Duration of postoperative analgesia 24 hours time between the injection of solution to the time when patient asks for first dose rescue medicine,patient satisfaction 24 hours Verbal Rating Score (VRS)

Countries

Thailand

Contacts

Public ContactKUMAR K C

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University

kumarchettri32@gmail.com0648590929

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026