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Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Pre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the relief of postoperative pain after craniotomy. Currently, postoperative pain after craniotomy in children is undertreated. Therefore, we aim to investigate whether pre-emptive scalp infiltration with ropivacaine (RP) plus MP is superior to RP alone to improve postoperative pain after craniotomy in children. METHODS AND ANALYSIS:The RP/MP versus RP trial is a prospective, single-centre, randomised, parallel-group study of 100 children aged 8-18 years undergoing intracranial surgery. Participants will be randomly allocated to receive pre-emptive scalp infiltration with either RP plus MP or RP alone. The primary outcome will be the cumulative fentanyl dose administered by patient-controlled intravenous analgesia within 24?hours postoperatively. The secondary outcomes will include postoperative Numerical Rating Scale scores, pain control satisfaction scores, length of stay and adverse events. Data will be analysed by the intention-to-treat principle. ETHICAL APPROVAL AND DISSEMINATION:The study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (Approval Number: KY 2018-066-02). The results will be disseminated in international academic meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03636165; Pre-results.

SUBMITTER: Zhao C

PROVIDER: S-EPMC6596953 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial.

Zhao Chunmei C Jia Yitong Y Jia Zipu Z Xiao Xiong X Luo Fang F

BMJ open 20190622 6

<h4>Introduction</h4>Pre-emptive scalp infiltration with local anaesthetics is the simplest and most effective method to prevent postoperative incisional pain. However, local infiltration of an anaesthetic only provides relatively short-term pain relief. Methylprednisolone (MP) treatment, administered as an adjuvant at the wound site, has been shown to provide satisfactory pain management after lumbar laminectomy. However, there is no evidence regarding the efficacy of MP infiltration for the re ...[more]

PMID: 31230016

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Project description:BackgroundModerate-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.MethodsThis 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.DiscussionThis 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 registrationChinese Clinical Trial Registry ChiCTR1800017386. Registered on 27 July 2018.

Project description:To compare the analgesic efficacy and safety of the sole local anesthetic ropivacaine with the combination of both local anesthetic ropivacaine and opioidergic analgesic sufentanil given epidurally on the labor pain control.After institutional review board approval and patient consent, a total of 500 nulliparas requesting epidural labor analgesia were enrolled and 481 eventually were randomized into 2 groups: a sole local anesthetic group (ropivacaine 0.125%) and a combination of local anesthetic and opioidergic analgesic group (0.125% ropivacaine + 0.3 μg/mL sufentanil). After the test dose, a 10-mL epidural analgesic solution was given in a single bolus, followed by intermittent bolus injection of 10 to 15 mL of the solution. The primary outcome was the analgesic efficacy measured using Numerical Rating Scale (NRS) of pain. Other maternal and infant variables were evaluated as secondary outcomes.A total of 346 participants completed the study. The median NRS pain score during the 1st stage of labor was significantly lower in the combination group 2.2 (interquartile range [IQR]: 1.8-2.7) comparing to the sole local analgesic group 2.4 (IQR: 2.0-2.8) (P < 0.0001). No significant difference was observed in NRS pain score prior epidural analgesia and during the 2nd stage of labor. Patients in both groups rated same satisfaction of analgesia. Patients in the sole local analgesic group experienced fewer side effects than those in the combination group (37.7% vs 47.2%, P = 0.082). The individual analgesia-related cost in the sole local analgesic group was less ($5.7 ± 2.06) than that in the combination group ($9.76 ± 3.54) (P < 0.0001). The incidence of 1-minute Apgar ≤ 7 was lower in the sole local analgesic group 2 (1.2%) than the combination group 10 (5.5%) (P = 0.038). No difference was found between other secondary outcomes.The sole local anesthetic ropivacaine produces a comparable labor analgesic effect as the combination of both local anesthetic ropivacaine and opioidergic analgesic sufentanil at different stages of labor (ΔNRS = 0.2) but the former has less side effects, lower cost, and less incidence of lower 1-minute Apgar scoring. These results imply the necessity of a systematic reevaluation of epidural labor analgesia with sole local anesthetics against combination regimens of local anesthetics and other opioids.

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.

Dataset Information

Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial.

Publications

Pre-emptive scalp infiltration with ropivacaine plus methylprednisolone versus ropivacaine alone for relief of postoperative pain after craniotomy in children (RP/MP vs RP): a study protocol for a randomised controlled trial.

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