Evidence map›Paper›PMID 38602618›Full record

Trial reportIrish journal of medical science2024

Comparison of sequential and mixture injections of opioids and hyperbaric bupivacaine for subarachnoid block for lower segment caesarean section: a randomised controlled study.

Moustafa M I Moustafa, Mohamed S Ali, Conan McCaul, Mostafa S Abbas

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Irish journal of medical science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04403724 (Comparison of Sequential and Mixture Injection of Opioids and Hyperbaric Bupivacaine for Subarachnoid Block for Elective Caesarean Section; a Randomised Controlled Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04403724 phase4completednot on this map

Comparison of Sequential and Mixture Injection of Opioids and Hyperbaric Bupivacaine for Subarachnoid Block for Elective Caesarean Section; a Randomised Controlled Study

TypeinterventionalSponsorAssiut UniversityRan2020 to 2021Enrolled126ConditionsBupivacaine Adverse Reaction, Regional Anesthesia Morbidity, Cesarean Section ComplicationsArmsBupivacaine-fentanyl-Morphine.
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Moustafa M I MoustafaMater Misericordiae University Hospital, Tandy's Lane, eircode K78V1W3, Dublin, Ireland. ghalahmm@yahoo.com.ORCID http://orcid.org/0000-0001-6761-9578
Mohamed S AliFaculty of Medicine, Assiut University, Asyut, Egypt.
Conan McCaulRotunda Hospital, Dublin, Ireland.
Mostafa S AbbasFaculty of Medicine, Assiut University, Asyut, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOpioids are commonly added to local anaesthetic for subarachnoid block for caesarean section due to their synergistic effects. The physiochemical characteristics of opioids suggest premixing with hyperbaric bupivacaine may limit their distribution within the CSF. We studied the effect of a separate injection with a combination of bupivacaine, morphine and fentanyl on block characteristics, haemodynamic changes, postoperative pain and patient satisfaction.

methodFollowing ethical approval and informed consent, a prospective double-blinded randomised controlled trial was performed in a university hospital. A total of 126 patients undergoing caesarean section were randomised to two groups. In group M, the premixed group, patients received 12 mg of hyperbaric bupivacaine, 20 mcg of fentanyl and 100 mcg of morphine injected as a single mixture. In group S, the separate injection group, patients received the same drugs in separate injections. Measurements included haemodynamics, block distribution, intra- and postoperative pain, as well as patient satisfaction.

resultsPatients in both groups had similar block height, time to maximum sensory block, time to block regression and motor block. However, haemodynamics were different between the groups. The proportion of systolic hypotension episodes was greater in group S [159/1320 (12.05%)] than group M [113/1452 (7.78%)], with P = 0.0002. Moreover, a greater amount of ephedrine was administered in group S than group M, with values 12.09 (8.1) and 9.09 (8.5) mg respectively (P = 0.001). Additionally, postoperative pain, as measured by the Visual Analogue Scale (VAS), was greater in group M, with a VAS of 4.6 (1.7), vs. group S, which recorded a VAS of 3.8 (2.0) (P = 0.017).

conclusionSequential injection of intrathecal opioids and hyperbaric bupivacaine resulted in greater early haemodynamic instability and slightly better postoperative analgesia without any difference in block height or patient satisfaction. CLINICAL

trial registrationNCT04403724.

Indexed as

Analgesics, OpioidAnesthetics, LocalBupivacaineCesarean SectionFentanylMorphinePostoperative PainAdultAnesthesia, SpinalDouble-Blind MethodFemaleHemodynamicsHumansNerve BlockPatient SatisfactionPregnancyAnalgesics, OpioidAnesthetics, LocalBupivacaineFentanylMorphineBlock characteristicsBupivacaineCaesarean sectionIntrathecalOpioidsPremixed injectionRandomised trialSequential injection

Identifiers

PMID38602618

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.