Efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients: a randomized clinical trial

This study was a prospective, randomized, parallel-group (allocation ratio 1:1), clinical trial, at Ain Shams University Hospitals (Maternity Hospital), Cairo, Egypt. The study adheres to CONSORT guidelines.

All patients signed a written informed consent before inclusion. Patients were informed about the use of numeric rating scale (NRS) to assess the severity of pain with a score from 0 to 10 (0 = no pain, 10 = most severe pain).

An investigator performed simple randomization using a computer-generated number table of random numbers in opaque and sealed envelope (SNOSE). Another investigator (not involved in sequence generation and allocation concealment) assessed patients for eligibility and assigned eligible patients to one of the studied groups. The assigned treatment was written on a card and sealed in opaque envelopes consecutively numbered. These envelopes were opened just immediately before administering the medication.

Sample size was calculated using PASS 11th release program, setting power at 90%, the alpha error at 5%. Result from a previous study (Puthenveettil et al. 2018) showed that the mean pain score at 2 h was 1.7 ± 2.3 in group B cases compared to 4.1 ± 1.4 in group A cases. Based on these results, a sample size of 20 patients in each group (40 total) will be needed, taking into account 20% dropout rate.

Inclusion criteria

We included a total of 40 patients post-cesarean section who had spinal anesthesia with 25G spinal needle, ASA I or II status, BMI < 35 kg/m2, and with active PDPH within 7 days after subarachnoid block and not relieved (NRS > 4) with standard treatment.

Exclusion criteria

We excluded patients who refuse to take part in the study, patients with BMI > 35 kg/m2 and ASA above II, patients with chronic headache or migraine, and patients with known coagulopathy, nasal septal deviation, polyp, history of nasal bleeding, and allergy to local anesthetics.

After obtaining the informed consent, patients were randomly divided into 2 equal groups, there was no blinding for the anesthetist and the patients, but the data collector was blind:

Paracetamol group (PG): (n = 20) Patients received 1 g paracetamol three times daily intravenously for 1 day. If adequate analgesia was not achieved (NRS > 4) after 2 h, rescue analgesia in the form of intravenous ketorolac 30 mg was given with a maximum dose of 120 mg/day.

Block group (SPGBG): (n = 20) Patients received bilateral SPGB, using 3-ml mixture of 2 ml of lignocaine 2% plus 1 ml (4 mg) dexamethasone in each nostril. All blocks were performed by the same anesthetist.

Bilateral SPGB was done with cotton-tipped applicator in the ward under monitoring where non-invasive blood pressure and O2 saturation probe were attached to the patient. The patient was in supine position with the neck extended. The anterior nares were inspected for polyps, tumors, or significant septal deviation. SPGB was done using transnasal approach. Few drops of lidocaine 2% was instilled into both anterior nares. Then, a long applicator with a cotton swab at the tip saturated with a 3-mL mixture of 2 mL lidocaine 2% plus 1 mL dexamethasone (4 mg) is then inserted parallel to the floor of the nose until resistance is encountered. The swab should be at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for 5 min and then removed. Similarly, the procedure is repeated in the other nostril.

The connective tissue and mucous membrane covering helps the diffusion and penetration of the drug. After 5 min, the patients in group B were asked to sit up to assess the presence of headache using numeric pain score (NRS). If adequate pain relief was not achieved after 2 h from a successful block (NRS > 4), the rescue analgesia in the form of intravenous ketorolac 30 mg with a maximum dose of 120 mg/day was given. Patients in both groups without adequate pain relief after 24 h from the beginning of the study were considered for EBP.

Standard monitoring of the patients such as mean arterial blood pressure and heart rate were recorded. Pain score was recorded before the procedure, 5 min, 15 min, 30 min, 1, 2, 4, 6, 8, 12, and 24 h after the procedure. Onset of analgesia (NRS less than 4), duration of analgesia (time to first rescue analgesic in min), adverse effects associated with the block, the total dose of ketorolac in (mg) during the study period, patient satisfaction, hospital stay for EBP, or hospital discharge after 24 h were also documented. Our study ended 24 h after recruiting patients for the trial.

Study endpoint

Failure to control PDPH with the suggested management.

Study outcomes

The primary outcome was to study the efficacy of SPGB for the treatment of PDPH assessed by reduction in pain score to < 4.

The secondary outcomes were to study the efficiency of the block by the assessment of onset and duration of analgesia, as well as the development of any side effects associated with the block, total dose of ketorolac, and hospital stay for EBP or hospital discharge after 24 h and patient satisfaction.

Statistical methods

The collected data were coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013. Quantitative variables tested for normality using Shapiro–Wilk test, then if normally distributed described as mean and standard deviation (SD) and compared using independent t-test, while if not normally distributed described as median and interquartile range (IQR) (1st − 3rd IQ) and compared using Mann–Whitney test. Qualitative data was described as number and percentage and compared using chi-square test and Fisher’s exact test for variables with small, expected numbers, while linear by linear associations used for ordinal variable. Long rank test was used to compare rate of morphine analgesia. The level of significance was taken at P value < 0.050 was significant, otherwise is non-significant.

留言 (0)

沒有登入
gif