Efficacy and safety of diclofenac suppository for postoperative pain relief after diagnostic hystero-laparoscopy and dye test: A double-blind, placebo-controlled, randomized trial.

Objective: To determine the efficacy and safety of rectal diclofenac for relieving postoperative pain following diagnostic hystero-laparoscopy and dye test (dHLD). Methods: A prospective, double-blind, placebo-controlled, randomized trial was conducted among women who underwent dHLD to evaluate fertility. The women received either rectal diclofenac with intramuscular pentazocine or intramuscular pentazocine with rectal placebo for postoperative analgesia. The median pain scores at different time points were assessed as the primary outcome measures using the Numerical Rating Scale for pain. The secondary outcome measures were analgesic consumption, time at which first analgesic was requested, satisfaction with pain relief and any adverse events. Results: In total, 108 participants were analysed (54 in each group, 1:1 ratio). The median score for postoperative pain was lower for the diclofenac group compared with the placebo group at 4 h (52.53 vs 56.47; p = 0.507), 6 h (50.48 vs 58.52; p = 0.174), 8 h (51.42 vs 57.65; p = 0.296), 10 h (51.35 vs 57.65; p = 0.285) and 12 h (52.45 vs 56.55; p = 0.485) post surgery, although the difference was not significant (p > 0.05). Seventeen participants required rescue analgesia with 30 mg of pentazocine: 11 at 4 h post surgery [5 (62.5 %) vs 6 (66.7 %)], three at 6 h post surgery [2 (25.0 %) vs 1 (11.1 %)], two at 8 h post surgery [1 (12.5 %) vs 1 (11.1 %)], and one at 12 h post surgery [0 vs 1 (11.1 %)] for the diclofenac and placebo groups respectively (p = 0.713). There were no significant differences in postoperative adverse effect profiles, overall patient satisfaction, and need for rescue analgesia between the two groups (p > 0.05). Conclusions: Postoperative use of rectal diclofenac and pentazocine is safe, but did not significantly improve pain scores, patient satisfaction and need for rescue analgesia following dHLD, compared with patients who received pentazocine and placebo. While a multi-modal approach to pain relief following dHLD does not appear to be significantly beneficial, a multi-centre study is needed to confirm or refute these findings.

A randomized clinical trial of Premaquick biomarkers versus transvaginal cervical length for pre-induction cervical assessment at term among pregnant women.

Objectives: To compare Premaquick biomarkers (combined insulin-like growth-factor binding protein 1 and interleukin-6) and cervical length measurement via transvaginal ultrasound for pre-induction cervical evaluation at term among pregnant women. Methods: A randomized clinical trial of consenting pregnant women at the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. The women were randomized equally into Premaquick group (n = 36) and transvaginal ultrasound group (n = 36). The cervix was adjudged 'ripe' if the Premaquick test was positive or if the trans-vaginal measured cervical length was less than 28 mm. The primary outcome measures were the proportions of women who needed prostaglandin analogue for cervical ripening and the proportion that achieved vaginal delivery after induction of labour. The trial was registered in Pan African clinical trial registry (PACTR) registry with approval number PACTR202001579275333. Results: The baseline characteristics were similar between the two groups (p > 0.05). There was no statistically significant difference between the two groups in terms of proportion of women that required prostaglandins for pre-induction cervical ripening (41.7 versus 47.2%, p = 0.427), vaginal delivery (77.8 versus 80.6%, p = 0.783), mean induction to delivery interval (22.9 ± 2.81 h versus 24.04 ± 3.20 h, p = 0.211), caesarean delivery (22.2 versus 19.4%, p = 0.783), proportion of neonate with birth asphyxia (8.30 versus 8.30%, p = 1.00) and proportion of neonate admitted into special care baby unit (16.7 versus 13.9%, p = 0.872). Subgroup analysis of participants with 'ripe' cervix at initial pre-induction assessment showed that the mean induction to active phase of labour interval and mean induction to delivery interval were significantly shorter in Premaquick than transvaginal ultrasound group. Conclusion: Pre-induction cervical assessment at term with either Premaquick biomarkers or transvaginal ultrasound for cervical length is effective, objective and safe with similar and comparable outcome. However, when compared with women with positive transvaginal ultrasound at initial assessment, women with positive Premaquick test at initial assessment showed a significantly shorter duration of onset of active phase of labour and delivery of baby following induction of labour.

Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy.

PURPOSE: To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures. METHODS: Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (n = 68) or Veress needle access (n = 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO2 required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis. RESULTS: Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min; p < 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO2 used, number of attempts for successful entry, and major/minor complications (p > 0.05). CONCLUSIONS: Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation. CLINICAL TRIAL REGISTRATION: PACTR201510000999192.

Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies.

BACKGROUND: Preterm birth (PTB) remains the foremost global cause of perinatal morbidity and mortality. Thus, the prevention of spontaneous PTB still remains of critical importance. In an attempt to prevent PTB in singleton pregnancies, cervical cerclage, in combination with other treatments, has been advocated. This is because, cervical cerclage is an intervention that is commonly recommended in women with a short cervix at high risk of preterm birth but, despite this, many women still deliver prematurely, as the biological mechanism is incompletely understood. Additionally, previous Cochrane Reviews have been published on the effectiveness of cervical cerclage in singleton and multiple pregnancies, however, none has evaluated the effectiveness of using cervical cerclage in combination with other treatments. OBJECTIVES: To assess whether antibiotics administration, vaginal pessary, reinforcing or second cerclage placement, tocolytic, progesterone, or other interventions at the time of cervical cerclage placement prolong singleton gestation in women at high risk of pregnancy loss based on prior history and/or ultrasound finding of 'short cervix' and/or physical examination. History-indicated cerclage is defined as a cerclage placed usually between 12 and 15 weeks gestation based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks gestation for transvaginal ultrasound cervical length < 20 mm in a woman without cervical dilatation. Physical exam-indicated cerclage is defined as a cerclage placed usually between 16 and 23 weeks gestation because of cervical dilatation of one or more centimetres detected on physical (manual) examination. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (26 September 2019), and reference lists of retrieved studies. SELECTION CRITERIA: We included published, unpublished or ongoing randomised controlled trial (RCTs). Studies using a cluster-RCT design were also eligible for inclusion in this review but none were identified. We excluded quasi-RCTs (e.g. those randomised by date of birth or hospital number) and studies using a cross-over design. We also excluded studies that specified addition of the combination therapy after cervical cerclage because the woman subsequently became symptomatic. We included studies comparing cervical cerclage in combination with one, two or more interventions with cervical cerclage alone in singleton pregnancies. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias, and evaluated the certainty of the evidence for this review's main outcomes. Data were checked for accuracy. Standard Cochrane review methods were used throughout. MAIN RESULTS: We identified two studies (involving a total of 73 women) comparing cervical cerclage alone to a different comparator. We also identified three ongoing studies (one investigating vaginal progesterone after cerclage, and two investigating cerclage plus pessary). One study (20 women), conducted in the UK, comparing cervical cerclage in combination with a tocolytic (salbutamol) with cervical cerclage alone in women with singleton pregnancy did not provide any useable data for this review. The other study (involving 53 women, with data from 50 women) took place in the USA and compared cervical cerclage in combination with a tocolytic (indomethacin) and antibiotics (cefazolin or clindamycin) versus cervical cerclage alone - this study did provide useable data for this review (and the study authors also provided additional data on request) but meta-analyses were not possible. This study was generally at a low risk of bias, apart from issues relating to blinding. We downgraded the certainty of evidence for serious risk of bias and imprecision (few participants, few events and wide 95% confidence intervals). Cervical cerclage in combination with an antibiotic and tocolytic versus cervical cerclage alone (one study, 50 women/babies) We are unclear about the effect of cervical cerclage in combination with antibiotics and a tocolytic compared with cervical cerclage alone on the risk of serious neonatal morbidity (RR 0.62, 95% CI 0.31 to 1.24; very low-certainty evidence); perinatal loss (data for miscarriage and stillbirth only - data not available for neonatal death) (RR 0.46, 95% CI 0.13 to 1.64; very low-certainty evidence) or preterm birth < 34 completed weeks of pregnancy (RR 0.78, 95% CI 0.44 to 1.40; very low-certainty evidence). There were no stillbirths (intrauterine death at 24 or more weeks). The trial authors did not report on the numbers of babies discharged home healthy (without obvious pathology) or on the risk of neonatal death. AUTHORS' CONCLUSIONS: Currently, there is insufficient evidence to evaluate the effect of combining a tocolytic (indomethacin) and antibiotics (cefazolin/clindamycin) with cervical cerclage compared with cervical cerclage alone for preventing spontaneous PTB in women with singleton pregnancies. Future studies should recruit sufficient numbers of women to provide meaningful results and should measure neonatal death and numbers of babies discharged home healthy, as well as other important outcomes listed in this review. We did not identify any studies looking at other treatments in combination with cervical cerclage. Future research needs to focus on the role of other interventions such as vaginal support pessary, reinforcing or second cervical cerclage placement, 17-alpha-hydroxyprogesterone caproate or dydrogesterone or vaginal micronised progesterone, omega-3 long chain polyunsaturated fatty acid supplementation and bed rest.

Anaesthetic agent usage and wastage during caesarean deliveries done with spinal anaesthesia in a labour ward theatre: a concern for the financial implication

Background: Local anaesthesia usage and wastage are common in the operation rooms. The wastage is often not given due considerations. Budgetary allocation for drugs is an identifiable area for cost-cutting and savings. Hence, the need to minimize wastage Objectives: To assess and estimate the amount of local anaesthesia usage and wastage in the labour ward theatre. Also, to analyze the financial implications of the wastages and suggest appropriate steps to reduce the wastages. Methodology: A prospective observational study conducted in the labour ward theatre of a tertiary care hospital. The amount of local anaesthesia administered to the patient during spinal anaesthesia prior to caesarean section was considered the dose used. The wastage was considered as the amount of local anaesthetic agents left unutilized in the syringes, ampules or vials after completion of each caesarean delivery. An estimation of the cost of wasted local anaesthetic agents was made. Result: The local anaesthetic agents being used in significant quantities were hyperbaric bupivacaine, plain lidocaine and lidocaine with adrenaline. The wastage was found more during the use of hyperbaric bupivacaine as the cost of its wastage formed the bulk (N75,000.00/ $210.10) of the estimated total cost of wasted local anaesthetic agents during the study period which was N88, 100.00 ($246.77). Conclusion: There were appropriate uses of the local anaesthesia with respect to the choice and doses for caesarean deliveries but there were wastages often ignored as infinitesimal. In the long run, the wastages become significant and the financial implication scale up the burden of health bills. Effective waste reduction strategies have input in the overall reduction of financial burden associated with health care. Emphasis should be t ailored towards awareness of these wastages among resident doctors and their prudent use of local anaesthesia

A Randomized Controlled Trial on Efficacy and Safety of Trocar-Site Infiltration with Lidocaine for Postoperative Pain Relief after Diagnostic Laparoscopy.

BACKGROUND/AIMS: To compare the efficacy and safety of trocar-site infiltration with lidocaine and no intervention for postoperative pain relief after diagnostic laparoscopy. METHODS: A randomized clinical trial of women with infertility scheduled for diagnostic laparoscopy without additional procedures in Life Institute for Endoscopy at Life Specialist Hospital, Nnewi, Nigeria. One hundred and ninety nine women were assigned at random to either trocar-site infiltration with lidocaine (n = 100) or no intervention (n = 99). Pain was assessed using visual analogue scale (VAS) scores at 2 and 4 h post surgery. The primary endpoints were postoperative pain control and time to first request of analgesia, while the secondary endpoints were total analgesic consumption, shoulder pain, and side effects. Evaluations between the groups were done according to the principle of intention-to-treat. RESULTS: Baseline characteristics were similar. A nonsignificant reduction was observed in the VAS in the intervention group at base line, 2 and 4 hours into the postoperative period in comparison with no intervention (p > 0.05), and the time to first analgesic requirement was not significantly prolonged (p > 0.05). The mean total consumption of rescue analgesia was not significantly reduced (p > 0.05). CONCLUSIONS: Postoperative injection of lidocaine in laparoscopy port sites did not significantly improve pain scores after diagnostic laparoscopy. CLINICAL TRIAL REGISTRATION: PACTR201611001263105.