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

Pain Clinical Trial

— PAINLESS  

Official title:

Effects of Pre-emptive Scalp Infiltration With Low-dose Ketorolac and Ropivacaine for Postoperative Pain Relief After Elective Supratentorial Craniotomy (PAINLESS): a Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04380298
• Other study ID #: KY-2018-034-02-7
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2020
• Source: Beijing Tiantan Hospital
• Contact: Fang Luo, M.D
• Phone: +8613611326978
• Email: 13611326978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Supratentorial Brain Tumor

Intervention

Drug:
• Ketorolac
30ml of local infiltration solution containing 60mg ropivacaine
• Ropivacaine
30ml of local infiltration solution containing 6mg ketorolac
• Epinephrine
30ml of local infiltration solution containing 0.1mg epinephrine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

References & Publications (4)

Andersen KV, Nikolajsen L, Haraldsted V, Odgaard A, Søballe K. Local infiltration analgesia for total knee arthroplasty: should ketorolac be added? Br J Anaesth. 2013 Aug;111(2):242-8. doi: 10.1093/bja/aet030. Epub 2013 Mar 20. — View Citation

Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008 Apr;79(2):174-83. doi: 10.1080/17453670710014950. — View Citation

Niemeläinen M, Kalliovalkama J, Aho AJ, Moilanen T, Eskelinen A. Single periarticular local infiltration analgesia reduces opiate consumption until 48 hours after total knee arthroplasty. A randomized placebo-controlled trial involving 56 patients. Acta Orthop. 2014 Dec;85(6):614-9. doi: 10.3109/17453674.2014.961399. Epub 2014 Sep 19. — View Citation

Song J, Li L, Yu P, Gao T, Liu K. Preemptive scalp infiltration with 0.5% ropivacaine and 1% lidocaine reduces postoperative pain after craniotomy. Acta Neurochir (Wien). 2015 Jun;157(6):993-8. doi: 10.1007/s00701-015-2394-8. Epub 2015 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative doses of patient-controlled analgesia (PCA) sufentanil consumption	cumulative doses of patient-controlled analgesia (PCA) butorphanol consumption from 0 to 48 h postoperatively The primary outcome measure will be cumulative doses of PCA butorphanol consumption from 0 to 48 h postoperatively	0 to 48 hours postoperatively
Secondary	The time to first request for PCA sufentanil	The time to first request for patient-controlled analgesia	0 to 48 hours postoperatively
Secondary	frequency of pressing PCA pump	frequency of pressing PCA pump	Within 48hours postoperatively
Secondary	numeral rating scale (NRS) Score	0 for"no pain" and 10 for "pain as severe as you can imagine"	at 2 hours, 4 hours, 8 hours, 24 hours, 48 hours postoperatively
Secondary	Pain control satisfaction score (PCSS) postoperatively	0 for unsatisfactory and 10 for very satisfactory	at 24 hours and 48 hours post-operation
Secondary	Ramsay sedation score (RSS)	1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to lightglabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to lightglabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.	at 2 hours, 4 hours, 8 hours, 24 hours and 48 hours postoperatively
Secondary	pulse oxygen saturation(SpO2)		1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	mean arterial blood pressure(MAP)		1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	heart rate(HR)		1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postoperatively
Secondary	respiratory rate(RR)		1 minutes before anesthesia induction, 1 minutes after anesthesia induction, 1 minutes after scalp infiltration, at the beginning of skull drilling, mater cutting and skin closure and at 2hours, 4 hours, 8 hours , 24 hours and 48 hours postope
Secondary	Length of hospital stay		Length of hospital stay, an arverage of 2 weeks
Secondary	postoperative nausea and vomiting(PONV)		within 48 hours postoperatively
Secondary	The presence of respiratory depression	respiratory rate <10 breaths per minute or SpO2 was<90 %	within 48 hours postoperatively
Secondary	The incidence of haematoma, wound infection or gastric ulcers	side effects	during hospitalization, within 2 weeks postoperatively