Dataset Information

Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.

ABSTRACT:

Background

Moderate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy. In addition, the neurosurgery operation time is relatively long, but the duration of action of SNB is limited. It is generally believed that postoperative SNB is better than preoperative SNB for postoperative analgesia. However, considering the concept of preemptive analgesia, we believe that preoperative SNB may achieve a longer postoperative analgesia effect than we expected.

Methods

This trial is a single-institution, prospective, randomized, controlled, double-blind study. A total of 180 children aged between 1 and 12?years who are undergoing elective craniotomy will be randomly allocated in a 1:1:1 ratio to three groups: group B (preoperative ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group). This randomization will be stratified by age in two strata (1-6?years and 7-12?years). The primary outcome is the total consumption of sufentanil within 24?h after surgery. The secondary outcomes include assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery.

Discussion

This study is designed to explore the effect and feasibility of SNB with ropivacaine for postoperative analgesia in pediatric patients undergoing craniotomy. Further aims are to compare the effects of preoperative and postoperative SNB on postoperative analgesia in order to identify whether there is a preemptive analgesic effect and determine the better time to implement SNB in pediatric patients during craniotomy.

Trial registration

Chinese Clinical Trial Registry ChiCTR1800017386. Registered on 27 July 2018.

SUBMITTER: Xiong W

PROVIDER: S-EPMC7318534 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.

Xiong Wei W Li Lu L Bao Di D Wang Yaxin Y Liang Yi Y Lu Pengwei P Zhang Di D Liu Gaifen G Qiao Lanxin L Zheng Na N Jin Xu X

Trials 20200626 1

<h4>Background</h4>Moderate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB ...[more]

PMID: 32586348

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Project description:BackgroundPain is often observed in pediatric patients after craniotomy procedures, which could lead to some serious postoperative complications. However, the optimal formula for postoperative analgesia for pediatric neurosurgery has not been well established. This study aimed to explore the optimal options and formulas for postoperative analgesia in pediatric neurosurgery.MethodsThree hundred and twenty patients aged 1 to 12-years old who underwent craniotomy were randomly assigned to receive 4 different regimens of patient-controlled analgesia. The formulas used were as follows: Control group included normal saline 100 ml, with a background infusion of 2 ml/h, bolus 0.5 ml; Fentanyl group was used with a background infusion of 0.1-0.2 μg/k·h, bolus 0.1-0.2 μg/kg; Morphine group was used with a background infusion of 10-20 μg/kg·h, bolus 10-20 μg/kg; while Tramadol group was used with a background infusion of 100-400 μg/kg·h, bolus 100-200 μg/kg. Postoperative pain scores and analgesia-related complication were recorded respectively. Comparative analysis was performed between the four groups.ResultsIn comparison of all groups with each other, lower pain scores were shown at 1 h and 8 h after surgery in Morphine group versus Tramadol, Fentanyl and Control groups (P < 0.05). Both Tramadol and Fentanyl groups showed lower pain scores in comparison to Control group (P < 0.05). Nausea and vomiting were observed more in Tramadol group in comparison to all other groups during the 48 h of PCIA usage after operation (P = 0.020). Much more rescue medicines including ibuprofen and morphine were used in Control group (CI = 0.000-0.019). Changes in consciousness and respiratory depression were not observed in study groups. Moderate-to-severe pain was observed in a total of 56 (17.5%) of the study population. Multiple regression analysis for identifying risk factors for moderate-to-severe pain revealed that, younger children (OR = 1.161, 1.027-1.312, P = 0.017), occipital craniotomy (OR = 0.374, 0.155-0.905, P = 0.029), and morphine treatment (OR = 0.077, 0.021-0.281, P < 0.001) are the relevant factors.ConclusionsCompared with other analgesic projects, PCIA or NCIA analgesia with morphine appears to be the safest and most effective postoperative analgesia program for pediatric patients who underwent neurosurgical operations.Trial registrationChinese Clinical Trial Registry. No: ChiCTR-IOC-15007676. Prospective registration. http://www.chictr.org.cn/index.aspx .

Project description:Background Postoperative pain after craniotomy is an important clinical concern because it might lead to brain hyperemia and elevated intracranial pressure. Considering the side effects of opioid, several studies have been conducted to investigate the effect of local anesthetics, especially the scalp block, on postoperative pain. However, the strength of evidence supporting this practice for postoperative pain after craniotomy was unclear and the best occasion of scalp block was also not identified. Therefore, we conducted a meta-analysis to evaluate the efficacy, safety, and the best occasion of scalp block for postoperative pain after craniotomy. Methods PubMed, Embase, and the Cochrane Library databases from database inception to October 10, 2021 were searched for all randomized controlled trials evaluating the effect of scalp block on postoperative pain after craniotomy. Data were assessed by StataMP 16 software. Results A total of 12 studies were included. A random-effect model was used to analyze all data. Patients under scalp block earned fewer scores than the non-scalp block group in visual analogue scale at the very early period (MD = −1.97, 95% CI = −3.07 to −0.88), early period (MD = −1.84, 95% CI = −2.95 to −0.73) and intermediate period (MD = −1.16, 95% CI = −1.84 to −0.49). Scalp block could also significantly prolong the time of the first request of rescue analgesia and reduce the use of additional analgesics without a significant difference in the incidence of complications. Subgroup analysis showed there was no significant difference in analgesia effect between pre-incision scalp block and post-incision scalp block in all periods. Conclusion Scalp block could lead to lower pain intensity scores, more time of the first request of rescue analgesia, and fewer analgesic drugs applied in the first 12 h after craniotomy. There was no significant difference between pre-incision and post-incision scalp block in the occurrence and severity of postoperative pain.

Project description:BackgroundPostoperative pain is a common occurrence in pediatric patients following craniotomy, often leading to negative outcomes. Intravenous dexmedetomidine and lidocaine are commonly used adjuvant medicines in general anesthesia to reduce perioperative opioid consumption and relieve postoperative pain in adults. While they show promise for use in pediatrics, the evidence of their application in pediatric craniotomy patients is limited. Therefore, we aimed to compare the effects of dexmedetomidine and lidocaine on postoperative pain in pediatric patients following craniotomy.MethodsWe conducted a randomized, double-blind, single-center trial on children scheduled for craniotomy. The 255 recruited participants aged 1-12 years were randomly assigned to intraoperatively receive a loading intravenous dose of either dexmedetomidine 1 μg·kg-1 or lidocaine 2 mg·kg-1 or normal saline for 15 min followed by dexmedetomidine 0.5 μg·kg-1·h-1 or lidocaine 1 mg·kg-1·h-1 or normal saline until the sutures of endocranium were completed. The primary outcome was the cumulative sufentanil consumption within 24 h post-surgery.ResultsA total of 241 patients were included in the statistical analysis. The primary outcome did not show any significant differences among the three groups (median (IQR) lidocaine group: 3.36 (1.32-5.64) μg vs. dexmedetomidine group: 3.12 (1.36-6.39) μg vs. control group 3.46 (1.77-7.62) μg, p = 0.485). Among the secondary outcomes, there was a statistically significant but small reduction in sufentanil consumption within 2 h, postoperative FLACC/WBFS/NRS pain scores within 4 h after surgery and postoperative Ramsay sedation scores in dexmedetomidine group (p < 0.05). Regarding postoperative complications, the incidence of electrolyte disturbance within 24 and 48 h after surgery was significantly higher in control group compared to the other two groups. There were no significant differences in intraoperative opioid consumption, postoperative frequency of remedy medication, or length of hospitalization among the three groups. No adverse events related to lidocaine or dexmedetomidine were observed.ConclusionsThere were no significant differences in the primary outcome among the three groups. Although dexmedetomidine showed some benefits in reducing postoperative opioid consumption within the first 2 h and pain intensity within the first 4 h post-surgery, these findings should be interpreted with caution. Further research is required to comprehensively assess the outcomes and determine the optimal administration strategy.Clinical trial registration[http://www.chictr.org.cn/index.aspx], identifier [ChiCTR1800019411].

Project description:Dexamethasone added to local anesthetic for brachial plexus block improves postoperative pain after arthroscopic rotator cuff repair, as compared with the use of local anesthetic alone. Dexamethasone is present in non-particulate form in local anesthetic solution, while betamethasone is partially present in particulate form. The particulate betamethasone gradually decays and is expected to cause its longer-lasting effect. This study investigated the postoperative analgesic effect of betamethasone added to ropivacaine for brachial plexus block in patients who underwent arthroscopic rotator cuff repair.This was a prospective, randomized, triple-blind study of 44 patients undergoing arthroscopic rotator cuff repair surgery. Ultrasound-guided interscalene brachial plexus block, involving 20 mL of 0.375 % ropivacaine (group R) or 19 mL of 0.375 % ropivacaine with 4 mg (1 mL) of betamethasone (group BR), was administered and surgery was performed under general anesthesia. After surgery, the pain score was recorded at 12 h after surgery, and on the first, second, and seventh postoperative day. Analgesia duration, offset time of motor block, frequency of rescue analgesic administration, postoperative nausea/vomiting, and sleep disturbance during the night after surgery were recorded. The numerical values were expressed as median [interquartile range]. P values < 0.05 were considered statistically significant.The duration of analgesia was significantly prolonged in group BR (group BR: 19.1 h [16.6, 20.9 h], group R: 13.3 h [11.6, 16.5 h], p < 0.001). The pain scores at 12 h after surgery and on the first and seventh day after surgery were significantly lower in group BR than in group R. The duration of motor block was significantly prolonged in group BR. The frequency of rescue analgesic administration and the sleep disturbance rate were significantly lower in group BR. There was no difference in postoperative nausea/vomiting between the two groups.Betamethasone added to local anesthetic in interscalene brachial plexus block improved postoperative pain after arthroscopic rotator cuff repair, and betamethasone prolonged the duration of analgesia by almost 6 h.University Hospital Medical Information Network Center Clinical Trials Registration System ( UMIN000012899 ).

Dataset Information

Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.

Background

Methods

Discussion

Trial registration

Publications

Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.

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