Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section: A Randomized Controlled Trial.
Description:
This prospective, randomised, double-blind trial will take place at B.P Koirala Institute of
Health Sciences, a University hospital situated in Nepal. Approval for the study has been
obtained from the institution ethical committee. After the trial is registered, recruitment
of the patient will be initiated. Consent for the participation in the study will be obtained
during pre-anaesthetic assessment visits in the evening before surgery. During this visit,
preoperative anxiety level (hospital anxiety and depression scale), pain catastrophizing
(assessed with pain catastrophizing scale), preoperative pain sensitivity (assessed with pain
pressure threshold and tolerance) will be recorded. The investigator will also educate the
patients regarding the use of NRS scores for postoperative pain and satisfaction ratings.
Patients will be randomly assigned in a 1:1 ratio to one of the two groups (morphine and
placebo groups). Randomization will be done in variable block sizes (4/6/8) by an internet
based random-number generator list.
Morphine group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10μg
of fentanyl (0.2 ml) and 100 μg of preservative free morphine (0.1 ml). Placebo group will
receive 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10μg of fentanyl (0.2 ml) and normal
saline (0.1ml).
Postoperatively, pain, opioid consumption, sedation, nausea or vomiting, pruritus, and
respiratory depression in the postanesthesia care unit (time 0 hours) and at 2, 6, 12, 24,
and 48 hours will be evaluated. The area of hyperalgesia around the surgical incision will be
assessed at 48 hrs postoperatively using a von Frey filament.
Patient satisfaction from postoperative analgesia will be assessed using a 5-point scale (1 =
very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied and 5 = very satisfied). At 8 wks
patients will be assessed for post-natal depression using Edinburgh postnatal depression
scale.
Patients will be contacted by telephone by one of the blinded investigator at 3, 6 months
after the surgery. The short form brief pain inventory will be used to determine post-CS
chronic pain
Condition:
Chronic Pain Post-Procedural
Treatment:
Morphine
Start Date:
April 1, 2018
Sponsor:
B.P. Koirala Institute of Health Sciences
For More Information:
https://clinicaltrials.gov/show/NCT03451695