Post Operative PainNCT05757388
Efficacy of Parecoxib Combined With Paracetamol in Mastectomy
A study testing Parecoxib + paracetamol and Normal saline in people with Post Operative Pain, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Parecoxib + paracetamol and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 28 Mar 2023to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with breast cancer undergoing elective mastectomy
- ASA physical status 1-3
Who cannot join
- Allergy to parecoxib, paracetamol, or sulfonamide
- History of opioid use
- Pregnant
- Renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Dr. Sirirat Tribuddharat
Khon Kaen, 40002
About this study
Official title: The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial
Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. The investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.
Read the detailed description
Patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. This may interfere with the daily life of the patients. Proper prophylaxis and management to control postoperative pain are essential. Morphine is the most common drug to control postoperative pain. However, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. Multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. Parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. The investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.
- Conditions
- Post Operative Pain
- Being tested
- Parecoxib + paracetamol, Normal saline
- Keywords
- postoperative pain, multimodal anagesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib + paracetamolDrug
Also called Study drugs
Administers after induction of anesthesia.
Normal salineDrug
Also called placebo
Administers after induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction. Receives: Drug: Parecoxib + paracetamol |
| Group C | Placebo comparator | Receives normal saline in the same process. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Postoperative morphine requirement
Measured: Up to 24 hours postoperatively
Secondary outcomes (3)
Postoperative pain score
Postoperative numeric rating score (0-10; higher score means a worse outcome) at rest and at movement
Measured: Up to 3 months postoperatively
Postoperative nausea/vomiting score
Postoperative nausea/vomiting score (0-3; higher score means a worse score)
Measured: Up to 24 hours postoperatively
Quality of life score
WHOQOL-BREF-THAI questionair (World Health Organization Quality of Life Brief - Thai: 26-130; higher score means a better outcome)
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start28 Mar 2023
- Primary completion1 May 2023 (estimated)
- Study completion10 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group P receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction or group C receives the normal saline in the same process.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Thepakorn Sathitkarnmanee, MD, Study chair, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757388
- Sponsor's protocol ID
- HE641269
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PubMed 16698416Woolf CJ, Max MB. Mechanism-based pain diagnosis: issues for analgesic drug development. Anesthesiology. 2001 Jul;95(1):241-9. doi: 10.1097/00000542-200107000-00034. No abstract available.
PubMed 11465563Schug SA. The role of COX-2 inhibitors in the treatment of postoperative pain. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S82-6. doi: 10.1097/00005344-200605001-00015.
PubMed 16785836Brett CN, Barnett SG, Pearson J. Postoperative plasma paracetamol levels following oral or intravenous paracetamol administration: a double-blind randomised controlled trial. Anaesth Intensive Care. 2012 Jan;40(1):166-71. doi: 10.1177/0310057X1204000121.
PubMed 22313079Nonaka T, Hara M, Miyamoto C, Sugita M, Yamamoto T. Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil on post-breast surgery pain: a randomized controlled trial. J Anesth. 2016 Jun;30(3):405-9. doi: 10.1007/s00540-016-2150-0. Epub 2016 Feb 16.
PubMed 26882922Schug SA, Parsons B, Li C, Xia F. The safety profile of parecoxib for the treatment of postoperative pain: a pooled analysis of 28 randomized, double-blind, placebo-controlled clinical trials and a review of over 10 years of postauthorization data. J Pain Res. 2017 Oct 10;10:2451-2459. doi: 10.2147/JPR.S136052. eCollection 2017.
PubMed 29066931
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05757388
- Acronym / sponsor ID
- HE641269
- Conditions
- Post Operative Pain
- Keywords
- postoperative pain, multimodal anagesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 10 May 2023 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. The investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.
Detailed description
Patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. This may interfere with the daily life of the patients. Proper prophylaxis and management to control postoperative pain are essential. Morphine is the most common drug to control postoperative pain. However, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. Multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. Parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. The investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group P receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction or group C receives the normal saline in the same process.
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Drug: Parecoxib + paracetamolReceives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction. |
| Group C | Placebo comparator | Drug: Normal salineReceives normal saline in the same process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with breast cancer undergoing elective mastectomy
- ASA physical status 1-3
Key exclusion criteria (4 listed)
- Allergy to parecoxib, paracetamol, or sulfonamide
- History of opioid use
- Pregnant
- Renal or hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parecoxib + paracetamolAlso: Study drugsAdministers after induction of anesthesia. | Drug | Group P |
| Normal salineAlso: placeboAdministers after induction of anesthesia. | Drug | Group C |
Primary outcome
Postoperative morphine consumption
Time frame: Up to 24 hours postoperatively
Postoperative morphine requirement
3 secondary outcomes
Postoperative pain score
Time frame: Up to 3 months postoperatively
Postoperative nausea/vomiting score
Time frame: Up to 24 hours postoperatively
Quality of life score
Time frame: Up to 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 16698416Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- Background: PubMed 11465563Woolf CJ, Max MB. Mechanism-based pain diagnosis: issues for analgesic drug development. Anesthesiology. 2001 Jul;95(1):241-9. doi: 10.1097/00000542-200107000-00034. No abstract available.
- Background: PubMed 16785836Schug SA. The role of COX-2 inhibitors in the treatment of postoperative pain. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S82-6. doi: 10.1097/00005344-200605001-00015.
- Background: PubMed 22313079Brett CN, Barnett SG, Pearson J. Postoperative plasma paracetamol levels following oral or intravenous paracetamol administration: a double-blind randomised controlled trial. Anaesth Intensive Care. 2012 Jan;40(1):166-71. doi: 10.1177/0310057X1204000121.
- Background: PubMed 26882922Nonaka T, Hara M, Miyamoto C, Sugita M, Yamamoto T. Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil on post-breast surgery pain: a randomized controlled trial. J Anesth. 2016 Jun;30(3):405-9. doi: 10.1007/s00540-016-2150-0. Epub 2016 Feb 16.
- Background: PubMed 29066931Schug SA, Parsons B, Li C, Xia F. The safety profile of parecoxib for the treatment of postoperative pain: a pooled analysis of 28 randomized, double-blind, placebo-controlled clinical trials and a review of over 10 years of postauthorization data. J Pain Res. 2017 Oct 10;10:2451-2459. doi: 10.2147/JPR.S136052. eCollection 2017.
- Individual participant dataSharing planned: No
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thepakorn Sathitkarnmanee, MD study chair
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parecoxib + paracetamol and Normal saline in people with Post Operative Pain, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thepakorn Sathitkarnmanee, MD (66-81-9547622, thepakorns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: Up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757388, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.