Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451695
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Asish Subedi, B.P. Koirala Institute of Health Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Pain Post-Procedural Drug: Morphine Drug: Placebo Phase 4

Detailed 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section: A Randomized Controlled Trial.
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : December 26, 2020
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Morphine group
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).
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 Comparator: Placebo group
Placebo group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and normal saline (0.1 ml).
Drug: 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)




Primary Outcome Measures :
  1. Number of participants with the incidence of post surgery chronic pain at 3 months following elective caesarean section [ Time Frame: 3 months after 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


Secondary Outcome Measures :
  1. Number of participants with the incidence of post surgery chronic pain at 6 months following elective caesarean section [ Time Frame: 6 month after 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

  2. Brief pain inventory (BPI) pain severity scores at 3 and 6 month after elective caesarean section between those receiving intrathecal morphine and normal saline [ Time Frame: 3 and 6 months after elective caesarean section ]
    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. Brief Pain Inventory (BPI) pain interference scores at 3 and 6 month after elective caesarean section between those receiving intrathecal morphine and normal saline [ Time Frame: 3 and 6 months after elective caesarean section ]
    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.

  4. Any pain medication or treatment received for relieving pain. If so, the amount of pain relieved. [ Time Frame: 3 and 6 months after elective caesarean section ]
    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.

  5. Numerical rating Scale (NRS) pain scores and opioid consumption post operatively [ Time Frame: 24 and 48 hrs after surgery ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451695


Locations
Layout table for location information
Nepal
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān Bāzār, Koshi, Nepal, 56700
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Layout table for additonal information
Responsible Party: Dr Asish Subedi, Doctor, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03451695    
Other Study ID Numbers: IRC/1183/017
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final research data will be stored in Mendeley. The final data will be released and shared during the publication process of the manuscript.
Supporting Materials: Study Protocol
Time Frame: The final research data and study protocol will be shared with the journal accepting the article for publication. It will be available simultaneously after publication of the article.
Access Criteria: The IPD may be accessed from the link provided in the published manuscript The IPD may also be shared to other researchers by the investigators upon request
URL: https://data.mendeley.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents