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Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine

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ClinicalTrials.gov Identifier: NCT02790099
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Lui Man Wa, Queen Mary Hospital, Hong Kong

Brief Summary:
Pain is the main obstacle in delaying postoperative recovery and leads to prolonged hospital stay. Administration of intrathecal morphine during spinal anaesthesia can provide effective pain control. However, it is associated with significant side effects including nausea, vomiting and itchiness. Also, it is not suitable in all patients, for example, those with morphine allergy, or severe respiratory disease. Surgical rectus sheath block involves injection of local anaesthetic agents into the rectus sheath space before closure of the wound. It has been shown to provide adequate pain control with less systemic side effects. The aim of the study is to evaluate the effectiveness of surgical rectus sheath block and intrathecal morphine in post-Caesarean section pain control.

Condition or disease Intervention/treatment Phase
Pain Drug: Bupivacaine Drug: Morphine Phase 4

Detailed Description:

The incidence of Caesarean section is increasing worldwide. Adequate post-operative analgesia is becoming an essential expectation of patients after Caesarean section. The process of recovery will be hindered by suboptimal pain control and eventually it will leads to immobilization and prolonged hospital stay.

Spinal anesthesia is usually the mode of anesthesia in pregnancy in view of increase general anesthetic risks. Intrathecal morphine can provide good pain control. However, pruritus can occur in up to 51% of patient, nausea and vomiting in up to 21%. Despite its significant side effects, there is an overall better patient satisfactory over use of intrathecal morphine. Due to its concern on respiratory depression, intrathecal morphine is not recommended in patients with severe respiratory disease, obstructive sleep apnoea or those receiving central nervous system depressants. As a result, there were numerous studies on alleviating the adverse effect and to search for other alternatives.

Rectus sheath block aims at blocking the terminal branches of 9th -12th intercostals nerve within the rectus sheath. They form rectus sheath plexus after piercing the posterior aspect of the rectus sheath and then branch into muscular and cutaneous branches. It can be given by anesthetist with or without ultrasound guidance. However, it involved additional time for administration of rectus sheath block and possibility of incorrect placement of catheter leading to ineffective analgesia.

On the contrary, surgical rectus sheath block was administrated by surgeon before closure of rectus sheath. It involves injection of local anesthetic in the rectus sheath space before closure of the wound under direct visual control. Surgical rectus sheath block was shown to be effective in postoperative pain control after transverse laparotomy in paediatrics patients. It was shown to be effective in postoperative pain control in Caesarean section without intrathecal morphine.

Surgical rectus sheath block may be a simple and safe alternative for intrathecal morphine. However, the evidence on its use in Obstetrics and Gynaecology was sparse and there is no study directly comparing the two different mode of analgesia. The aim of the study is to evaluate the use of surgical rectus sheath and intrathecal morphine for postoperative pain in Caesarean section; and its side effects profile.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rectus sheath block only
Patient will be given surgical rectus sheath block postoperatively with 40ml of bupivacaine (2.5mg/mL) and 0.1ml of normal saline will be injected intrathecally at time of spinal anaesthesia.
Drug: Bupivacaine
Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.
Other Name: Marcain

Active Comparator: Intrathecal morphine group
0.1mg preservative free morphine will be injected intrathecally at time of spinal anesthesia and 40ml of normal saline will be injected as rectus sheath block.
Drug: Morphine
0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.

Active Comparator: Both intervention
Patient will be given 0.1mg preservative free morphine intrathecally at time of spinal anaesthesia and surgical rectus sheath block with 40ml of bupivacaine (2.5mg/ml).
Drug: Bupivacaine
Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.
Other Name: Marcain

Drug: Morphine
0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.




Primary Outcome Measures :
  1. Pain score [ Time Frame: at 12 hours postoperatively ]
    Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)


Secondary Outcome Measures :
  1. Requirement of oral analgesics [ Time Frame: within 24hours postoperatively ]
    Paracetamol 1gram four times a day on request basis will be prescribed. The number of time requiring paracetamol will be recorded. The need of additional analgesics will be recorded.

  2. Time of mobilization [ Time Frame: 3days postoperatively ]
    time of starting mobilization, defined as able to get out of bed without assistance

  3. Side effect [ Time Frame: 3days postoperatively ]
    side effects including itchiness, nausea/ vomiting, sedation

  4. Pain score [ Time Frame: Immediate postoperative ]
    Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10), will be accessed at the recovery room after the operation.

  5. Pain score [ Time Frame: 4hours postoperatively ]
    Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

  6. Pain score [ Time Frame: 8hrs postoperatively ]
    Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)

  7. Pain score [ Time Frame: 24hrs postoperatively ]
    Pain score at rest and movement (elevation of head and shoulder at supine position), using visual analogue scale (0-10)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned for elective lower segment Caesarean section, using suprapubic transverse incision
  • Willing and able to participate after the study has been explained
  • Those understand either Cantonese, Putonghua or English

Exclusion Criteria:

  • Patient with treatment for chronic pain
  • History of narcotic abuse/ recreational drug use
  • Allergy to opioids/ local anesthesia/ paracetamol/ tramadol/ non-steroidal anti-inflammatory drugs
  • Patient with pre-eclampsia

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): NCT02790099


Locations
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Hong Kong
Department of Obstetrics and Gynaecology, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Queen Mary Hospital, Hong Kong
Investigators
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Study Chair: Ernest H. Y. Ng Queen Mary Hospital, Hong Kong
Publications of Results:
Other Publications:
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Responsible Party: Lui Man Wa, Dr, Queen Mary Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02790099    
Other Study ID Numbers: UW 14-345
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: That's for patient privacy that individual participant data will not be available.
Keywords provided by Lui Man Wa, Queen Mary Hospital, Hong Kong:
Pain
Postoperative pain control
Rectus sheath block
Intrathecal morphine
Caesarean section
Additional relevant MeSH terms:
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Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics