Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section

Chronic Pain Post-Procedural Clinical Trial

Official title:

Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451695
• Other study ID #: IRC/1183/017
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incidence of chronic post-surgical pain (CPSP) after caesarean section (CS) is reported to be as high as 18%, reflecting it to be a significant clinical problem. Studies related to prevention of progression of acute post-CS pain to its chronicity are sparse. Current guidelines on post-CS analgesia recommend the use of intrathecal (IT) opioids to spinal anaesthesia for improved post-CS pain relief. Despite its frequent use, studies related to the IT morphine use and its association with post-CS chronic pain are lacking.

A recent prospective observation study revealed a significant reduction in persistent pain after CS when IT morphine was used as an adjuvant to spinal anaesthesia. However, there is no any randomized controlled trial (RCT) that has explored this association to date. We hypothesized that spinal morphine would reduce the incidence of persistent pain after CS.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 30, 2021
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Woman in American Society of Anesthesiologists (ASA) physical status classification II with full-term singleton pregnancy undergoing planned CS under spinal anesthesia.

Exclusion Criteria:

• contraindication to spinal anaesthesia, height<150 cm, ASA > II, BMI> 40, allergy to any drug used in the study, recent opioid exposure, substance abuse, significant cardiovascular, renal, or hepatic disease; and known fetal abnormalities.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Post-Procedural

Intervention

Drug:
• Morphine
Morphine group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 µg of fentanyl (0.2 ml) and 100 µg of preservative free morphine (0.1 ml).
• Placebo
Placebo group will receive 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 µg of fentanyl (0.2 ml) and normal saline (0.1ml)

Locations

Country	Name	City	State
Nepal	BP Koirala Institute of Health Sciences (BPKIHS)	Dharan Bazar	Koshi

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with the incidence of post surgery chronic pain at 3 months following elective caesarean section	To find the number of participants with the incidence of post surgery chronic pain at 3 months following elective caesarean section in those receiving Intrathecal morphine and normal saline	3 months after elective caesarean section
Secondary	Number of participants with the incidence of post surgery chronic pain at 6 months following elective caesarean section	To find the number of participants with the incidence of post surgery chronic pain at 6 months following elective caesarean section in those receiving Intrathecal morphine and normal saline	6 month after elective caesarean section
Secondary	Brief pain inventory (BPI) pain severity scores at 3 and 6 month after elective caesarean section between those receiving intrathecal morphine and normal saline	Short form Brief pain inventory (BPI) pain severity scores: Pain is rated on a 0 to 10 numerical rating scale, with 0="no pain" or and 10=pain "as bad as you can imagine." Participants rate their worst, least, and average pain over the last seven days, as well as their pain right now.	3 and 6 months after elective caesarean section
Secondary	Brief Pain Inventory (BPI) pain interference scores at 3 and 6 month after elective caesarean section between those receiving intrathecal morphine and normal saline	Short form Brief pain inventory (BPI) pain interference scores: Participants rate how much pain interfered with various daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The interference items is presented with 0-10 scales, with 0=no interference and 10=interferes completely.	3 and 6 months after elective caesarean section
Secondary	Any pain medication or treatment received for relieving pain. If so, the amount of pain relieved.	Currently use of pain medications, its dosages or any other treatment will be recorded.In the last 24 hours, how much relief have pain treatment or medications provided. Please rate in 0-100% where 0% is no relief, 100% complete relief.	3 and 6 months after elective caesarean section
Secondary	Numerical rating Scale (NRS) pain scores and opioid consumption post operatively	Post operative pain intensity will be assessed using Numerical rating scale(NRS), where 0="no pain" or and 10=pain "as bad as you can imagine." Total opioid consumption will be calculated as total morphine or equivalent in mg.	24 and 48 hrs after surgery