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Completed

NCT Number: NCT02790099

Comparison of Surgical Rectus Sheath Block and Intrathecal Morphine

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics and Gynaecology, Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.

Other names: Marcain

Morphine

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Official study title

Double-blinded Randomized Controlled Study for Comparison of Surgical Rectus Sheath and Intrathecal Morphine for Postoperative Pain Control After Caesarean Section

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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