Comparison between neostigmine and atropine added to standard post-dural puncture headache regimen versus standard regimen alone

The objective of this study is to compare the treatment efficacy of adding neostigmine and atropine to standard treatment regimen versus standard regimen alone for post-dural puncture headache (PDPH) in patients after caesarian section delivery.

Double blind, single center, interventional randomized controlled trial Divided into two groups: Modified treatment group (n=65) Standard treatment group (n=65) Studied in two phases (Pain scores in phase 1 and adverse effects in phase 2) The patient were randomized using non-probability consecutive sampling via lottery method on cards given to the resident on duty in the intervention suite

This was a double-blind study, carried out at the Dept of Anesthesiology, CMH Kharian. sealed envelopes containing pre-made regimes were given in both groups with the administering anesthetist and the anesthetist recording the results unaware of the drug formulation and the study protocol

Inclusion criteria included all patients with post-dural puncture headache presenting to the anesthesia clinic 48-72 hours after caesarian delivery. Exclusion criteria included patients unwilling for IV or oral therapy, refusal to be included in the study, patients with allergy to either atropine, neostigmine, paracetamol and/or ibuprofen, patients with known history of migraine, cluster headache

Patients in the standard regimen received the institute followed conservative management. Patients in the modified regimen received the same protocol and drugs of the standard regimen as well as IV neostigmine 20 mcg/kg and atropine 10 mcg/kg in 20 ml.

Primary variables measured was pain threshold on visual analog scale (VAS)12 at 6,12,24,48, and 72 hours after the start of treatment.

Double blind interventional randomized controlled trial. This randomized controlled trial was carried out at Anesthesia department of Combined Military Hospital, Kharian The patients were divided into the modified treatment group (Group M) (n=65) and the standard treatment group (Group S) (n=65) after randomization. One was given the standard regimen and the other received the modified regimen with atropine added. The method of randomization was simple non-probability consecutive sampling via lottery method. The lottery envelopes were placed in the pre-anesthesia clinic and patients presenting for treatment of PDPH were asked to pick one at random and segregated into one of the two groups. The randomization was done in sealed envelopes with the resident consultant on duty containing pre-prepared treatment vials as unmarked syringes to be given in both groups according to the treatment guide

This was a double-blind study and once the patients were divided into the two groups, both the drug administering anesthetist and the anesthetist recording the results were unaware of the study protocol or the randomization group details. The lottery envelopes were placed in the pre-anesthesia clinic and patients presenting for treatment of PDPH were asked to pick one at random and segregated into one of the two groups. The randomization was done in sealed envelopes with the resident consultant on duty containing pre-prepared treatment vials as unmarked syringes to be given in both groups according to the treatment guide. Both the patient as well as the resident giving the treatment was unaware of the drugs being given as well as the study protocol. Proforma for analysis was also marked with nondescript group to blind the assessor of the outcome of each group of study.

The data will be shared after the manuscript approval by the concerned publishing journal. Request to be forwarded to the main focal person given in details by email and after permission would be shared by email to the requesting person/organization.

After approval of manuscript for publication and would be available with the focal person and organization indefinitely

For research and academic institutions after permission from the focal person.

For research and academic purposes only Focal person given in details and email address provided to be used for all queries

From the focal person via email after formal request and approval from the institute. Process would be done by the focal person.

A formal email requesting the data required with official name and designation of the person requiring. Would be given after focal person receives confirmation from own institute to share the data. Approximate processing time 7-10 days.