Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-08-31

Brief Summary

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The PAINLESS study is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled clinical pilot study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.

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Detailed Description

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Conditions

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Pain Supratentorial Brain Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The ketorolac group

Patients assigned to the ketorolac group will receive pre-emptive scalp infiltration with 30ml of local infiltration solution containing 60 mg ropivacaine, 6 mg ketorolac and 0.1mg epinephrine.

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

30ml of local infiltration solution containing 60mg ropivacaine

Ropivacaine

Intervention Type DRUG

30ml of local infiltration solution containing 6mg ketorolac

Epinephrine

Intervention Type DRUG

30ml of local infiltration solution containing 0.1mg epinephrine

The control group

In the control group, preoperative peri-incisional scalpinfiltration will be performed using 30ml of 60 mgropivacaine and 0.1mg epinephrine.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

30ml of local infiltration solution containing 6mg ketorolac

Epinephrine

Intervention Type DRUG

30ml of local infiltration solution containing 0.1mg epinephrine

Interventions

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Ketorolac

30ml of local infiltration solution containing 60mg ropivacaine

Intervention Type DRUG

Ropivacaine

30ml of local infiltration solution containing 6mg ketorolac

Intervention Type DRUG

Epinephrine

30ml of local infiltration solution containing 0.1mg epinephrine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled for elective supratentorial tumour resection;
* Planned general anaesthesia;
* American Society of Anesthesiologists (ASA) physical status I - II;
* Age ranging from 18 to 65 years old;
* Participates required to fix their head in a head clamp intraoperatively;
* Participates with an anticipated awake within 2 hours after surgery.

Exclusion Criteria

* Allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine;
* Expected delayed extubation or no plan to extubate;
* History of neurosurgeries;
* Long-term use of analgesics and sedatives (more than 2 weeks)
* Receiving any painkiller within 24 h before the operation;
* Extreme body mass index (BMI) (less than 15 or more than 35);
* Patients with impaired cardiopulmonary;
* Patients with impaired renal function;
* Patients with impaired hepatic function;
* History of chronic headache;
* Patients with cognitive deficit;
* Patients with intellectual disability;
* Patients with uncontrolled epilepsy;
* Patients with psychiatric disorders;
* Difficulties in using PCA device
* Difficulties in understanding the use of numeral rating scale (NRS) ;
* Patients with suspected intracranial hypertension;
* Pregnant or at breastfeeding;
* Infection at the incisional site;
* History of radiation therapy and chemotherapy preoperatively
* With great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No