Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults

NCT04073069 | Completed Phase 4 DMC

• 1 other identifier: KY 2018-034-02-3
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications, such as arterial hypertension, intracranial hemorrhage, prolonged hospital stay, and mortality. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as diprospan as an adjuvant to local anesthetics intra-articular injected locally ameliorated pain intensity in knee osteoarthritis or in total knee arthroplasty. However, there has not been reported about local application of diprospan on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Conditions

Pain, Postoperative; Post-Craniotomy Headache

Keywords

Postoperative Pain;; Post-Craniotomy Headache; Ropivacaine; Pre-emptive Scalp Infiltration; Diprospan

Outcome Measures

Primary Outcomes (1)

• Cumulative sufentanil consumption within 48 hours postoperatively

  All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.

  Within 48 hours after the operation

Secondary Outcomes (13)

• The number of participants who have no sufentanil consumption

  Within 48 hours after the operation

• The first time to press the patient-controlled analgesia button

  Within 48 hours after the operation

• The total times that participants press patient-controlled analgesia button

  Within 48 hours postoperatively

• Numerical rating scale (NRS)

  At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery

• Postoperative nausea and vomiting

  At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery

Study Arms (2)

The DR group

EXPERIMENTAL

Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, 0.5ml diprospan, plus 14.5ml saline;

Drug: The DR group

The R group

ACTIVE COMPARATOR

Participates received peri-incisional scalp infiltration with 15ml ropivacaine 1% wt/vol, plus 15ml saline;

Drug: The R group

Interventions

The DR group DRUG

Miscible liquid of diprospan and ropivacaine in this study will be peri-incisional scalp infiltration with 0.5 ml diprospan, 15 ml 1% ropivacaine and 14.5 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.

The DR group

The R group DRUG

Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 15 ml 1% ropivacaine and 15 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.

The R group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
• American Society of Anesthesiologists (ASA) physical status of I , II or III;
• Participates with an anticipated fully recovery within 2 hours postoperatively.

You may not qualify if:

• History of craniotomy;
• Expected delayed extubation or no plan to extubate;
• Participants who cannot use a patient-controlled analgesia (PCA) device;
• Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
• Extreme body mass index (BMI) (\< 15 or \> 35);
• Allergy to opioids, diprospan or ropivacaine;
• History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
• History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
• Pregnant or at breastfeeding;
• Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
• Preoperative Glasgow Coma Scale\< 15;
• Suspicion of intracranial hypertension;
• Peri-incisional infection;
• Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (6)

• Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.

  PMID: 17410701 BACKGROUND

• Dunn LK, Naik BI, Nemergut EC, Durieux ME. Post-Craniotomy Pain Management: Beyond Opioids. Curr Neurol Neurosci Rep. 2016 Oct;16(10):93. doi: 10.1007/s11910-016-0693-y.

  PMID: 27604271 BACKGROUND

• Chaki T, Sugino S, Janicki PK, Ishioka Y, Hatakeyama Y, Hayase T, Kaneuchi-Yamashita M, Kohri N, Yamakage M. Efficacy and Safety of a Lidocaine and Ropivacaine Mixture for Scalp Nerve Block and Local Infiltration Anesthesia in Patients Undergoing Awake Craniotomy. J Neurosurg Anesthesiol. 2016 Jan;28(1):1-5. doi: 10.1097/ANA.0000000000000149.

  PMID: 25493926 BACKGROUND

• Romsing J, Moiniche S, Ostergaard D, Dahl JB. Local infiltration with NSAIDs for postoperative analgesia: evidence for a peripheral analgesic action. Acta Anaesthesiol Scand. 2000 Jul;44(6):672-83. doi: 10.1034/j.1399-6576.2000.440607.x.

  PMID: 10903014 BACKGROUND

• Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.

  PMID: 24403757 BACKGROUND

• Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.

  PMID: 27716229 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 28, 2019
• Study Start: September 3, 2019
• Primary Completion: August 15, 2020
• Study Completion: February 15, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)