Regional Scalp Block Versus IV Parecoxib for Post-operative Cranioplasty Surgery Pain: A Comparison of Pain Score.

NCT05442411 | Completed Phase 1

• 1 other identifier: USM/ JEPeM/19080504
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the post cranioplasty pain score using scalp block versus conventional analgesia using IV Parecoxib and requirement of morphine between two groups as rescue analgesia

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• pain score

  visual analog score

  12 hours

Secondary Outcomes (1)

• total morpine requirement

  12 hours

Study Arms (2)

post operative pain score

EXPERIMENTAL

post operative pain score at 1hour, 2 hour, 4 hour, 6 hour, and 12 hour

Drug: Ropivacaine 0.75% Injectable Solution

morphine requirement

EXPERIMENTAL

post operative PCA morphine requirement

Drug: Ropivacaine 0.75% Injectable Solution

Interventions

Ropivacaine 0.75% Injectable Solution DRUG

comparison of scalp block vs conventional post operative parecoxib

Also known as: parecoxib 40mg

morphine requirement; post operative pain score

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Fifty-eight patients with written informed consent and American Society of Anaesthesiologist (ASA) physical status I and II, aged 18 to 60 years old, pre-operative GCS of 15 and underwent elective cranioplasty surgery under general anaesthesia (GA) between September 2019 until March 2022 were selected for the study and randomized by computer generated randomization into two groups; Regional Scalp Block (n = 29) and IV Parecoxib (n = 29). The patients were excluded from this study if they were a known allergy to local anesthesia or NSAIDS, had risk for bleeding tendency or coagulopathy, low preoperative platelets count (\< 100 x103/mL) or with underlying bronchial asthma. The patient withdrawn from the study if he or she was not able to score post pain using Visual analog Scale (VAS) or had redo surgery for postoperative bleeding.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

School Of Medical Sciences, Health Campus, Universioti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; parecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant is blineded to the treatment as they was givemn intraopeartively the pain score assessor is blinded since the assessment was done postoperatively
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer and Neuroanaesthesiologist

Model Details: randomised contrrolled trial

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 5, 2022
• Study Start: March 9, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 30, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Locations

MY (1)